UCB (OTC:UCBJF) Stock, Quote.Headers.trade-ideas

UCB is a Belgium-based biopharma firm focused on the development of novel therapies for the treatment of central nervous system and immunologic diseases. Historically, revenue was derived from allergy medicine Zyrtec and epilepsy drug Keppra, which have both lost patent protection. The firm's key products are Cimzia (immunology), Vimpat (epilepsy), Neupro (Parkinson's disease and restless leg syndrome), Briviact (epilepsy), Bimzelx (psoriasis), Evenity (osteoporosis), Nayzilam (cluster seizures), and Fintepla (Dravet Syndrome and Lennox-Gastaut Syndrome).

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Truist Securities initiated coverage on Longboard Pharmaceuticals, citing it as a CNS-focused biotech with high-value epilepsy assets.

Longboard Pharmaceuticals Boasts High-Value Epilepsy Assets, Analyst Initiates Coverage

Johnson Johnson logo in front of one of their office buildings, Fremont, East San Francisco bay area, California. Image By Sundry Photography Via Shutterstock

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Johnson &amp; Johnson has submitted a Biologics License Application (BLA) to the FDA for nipocalimab, seeking its first global approval for generalized myasthenia gravis (gMG). This submission follows positive Phase 3 study results and could position nipocalimab as a key competitor against existing gMG treatments like UCB&#39;s Rystiggo and Argenx&#39;s Vyvgart.

Johnson &amp; Johnson Seeks FDA Approval For Muscle Weakness Drug And Gears Up Showdown With Argenx and UCB

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UCB announces a $680 million strategic divestment deal in China, selling its neurology and allergy business to CBC Group and Mubadala while focusing on innovative therapies in the region.

Belgium-Based Pharma Firm UCB To Offload China Neurology, Allergy Business For $680M To Asset Management Companies

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Truist Securities initiated coverage on Longboard Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LBPH#NASDAQ">LBPH</a>), citing it as a CNS-focused biotech with <a target="_blank" href="https://www.benzinga.com/quote/Lbph" rel="noreferrer noopener">high-value epilepsy assets</a>.
The company plans to advance its lead drug bexicaserin&nbsp;(LP352), into the Phase 3 program later this year.
The FDA has granted Breakthrough Therapy designation for bexicaserin for seizures associated with Developmental and Epileptic Encephalopathies (DEEs) for patients two years of age and older.
Earlier this year, Longboard reported topline data from the PACIFIC Phase 1b/2a trial evaluating bexicaserin in <a target="_blank" href="https://www.benzinga.com/analyst-ratings/analyst-color/24/01/36454681/theres-optimism-around-longboard-pharmaceuticals-anti-seizure-candidate-analyst-boo" rel="noreferrer noopener">participants with DEEs</a>.
Recently, the company revealed interim results from its ongoing 52-week open-label extension of the PACIFIC Study evaluating bexicaserin (LP352) in participants ages 12-65 with DEEs.
Bexicaserin achieved an overall median seizure reduction of 57.7% in countable motor seizures over an approximate 9-<a target="_blank" href="https://www.benzinga.com/pressreleases/24/09/b40763452/longboard-pharmaceuticals-announces-positive-interim-analysis-results-from-the-open-label-extensio" rel="noreferrer noopener">month treatment period</a>.
Longboard is also evaluating LP659, which is in development for the potential treatment of rare neuroinflammatory conditions.
Truist writes bexicaserin is competitive to current market leader UCB SA (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJY#OTC">UCBJY</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJF#OTC">UCBJF</a>) Fintepla (fenfluramine) in epilepsy.
The analyst initiates with a Buy rating and a <a target="_blank" href="https://www.benzinga.com/quote/LBPH/analyst-ratings" rel="noreferrer noopener">price target of $60</a>.
Fintepla is on track for approximately $1 billion in estimated sales by 2027 per UCB Pharma.
The analyst notes that, unlike fenfluramine, bexicaserin does not bind to the 5HT2B receptor, which is linked to the heart-related side effects seen with Fintepla.
&#8220;Based on bexicaserin&#8217;s superior safety and comparable efficacy to Fintepla, we think bexicaserin could not only displace Fintepla but also further expand the market, which remains under-penetrated at around 5%,&#8221; Truist analyst writes.
Price Action: LBPH stock is up 0.20% at $34.58 at last check Tuesday.
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Thursday, Johnson &amp; Johnson (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>) announced the submission of a Biologics License Application (BLA) to the FDA seeking the first approval of nipocalimab globally for generalized <a target="_blank" href="https://www.benzinga.com/pressreleases/24/08/n40623420/johnson-johnson-seeks-first-approval-of-nipocalimab-to-treat-broadest-population-living-with-antib" rel="noreferrer noopener">myasthenia gravis (gMG)</a>.&nbsp;
gMG is an autoantibody-driven neuromuscular disease characterized by fluctuating muscle weakness.
The update marks the first FDA submission for nipocalimab, an investigational treatment that binds with high affinity and specificity to block FcRn and reduce autoantibody levels.
Also Read: <a target="_blank" href="https://www.benzinga.com/analyst-ratings/analyst-color/24/04/38189788/cartesian-therapeutics-rare-disease-candidate-shows-long-lasting-benefit-over-argen" rel="noreferrer noopener">Cartesian Therapeutics&#8217; Rare Disease Candidate Shows Long Lasting Benefit Over Argenx&#8217;s Vyvgart, Analyst Initiates With Buy</a>.
The application included data from the Phase 3 Vivacity-MG3 study, which showed that outcomes for a broad population of antibody-positive participants who received nipocalimab plus standard of care (SOC) were superior compared to those who received placebo plus SOC.
In the Phase 3 VIVACITY study in gMG, nipocalimab met the primary endpoint, achieving a statistically significant reduction in MG-ADL score from baseline over weeks 22 to 24 <a target="_blank" href="https://www.benzinga.com/general/biotech/24/02/36938146/new-hope-for-patients-with-chronic-autoimmune-conditions-johnson-johnsons-investigational-drug-me" rel="noreferrer noopener">compared with placebo</a>.&nbsp;
Earlier this year, at the American Academy of Neurology Annual Meeting, Johnson &amp; Johnson&nbsp;presented data&nbsp;on the molecular properties of nipocalimab.
Last year, the FDA approved&nbsp;UCB SA&#8217;s (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJF#OTC">UCBJF</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJY#OTC">UCBJY</a>)
Rystiggo (rozanolixizumab-noli) for generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) or anti-muscle-specific tyrosine&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/23/06/33029533/fda-approves-rystiggo-the-only-treatment-for-two-most-common-subtypes-of-generalized-myasthenia-g" rel="noreferrer noopener">kinase (MuSK) antibody positive</a>.
The company says Rystiggo is the only FDA-approved treatment in adults for anti-AChR and anti-MuSK antibody-positive gMG, the two most common subtypes of gMG.
Johnson &amp; Johnson&#8217;s drug will also compete with Argenx SE&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARGX#NASDAQ">ARGX</a>) Vyvgart Hytrulo for gMG in adult patients who are anti-acetylcholine&nbsp;<a target="_blank" href="https://www.benzinga.com/analyst-ratings/analyst-color/23/06/32942320/argenxs-vyvgart-hytrulo-becomes-first-fda-approved-subcutaneous-option-for-generali" rel="noreferrer noopener">receptor antibody positive</a>.&nbsp;
The drug is available in subcutaneous and intravenous injections.
Price Action: JNJ stock is up 0.36% at $164.51 at the last check on Thursday.
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Image By Sundry Photography Via Shutterstock

Johnson & Johnson Seeks FDA Approval For Muscle Weakness Drug And Gears Up Showdown With Argenx and UCB

European&nbsp;biopharmaceutical company UCB SA (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJF#OTC">UCBJF</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJY#OTC">UCBJY</a>) announced a $680 million strategic divestment deal in China.
The transaction involves the sale, divestment, and license of UCB&#8217;s mature business (neurology and allergy) in China to CBC Group, an Asia-based healthcare-dedicated asset management group, and Mubadala, an Abu Dhabi-based investment company.
&#8220;In the short term, UCB is exploring the launch of novel medicines in immunology, neurology, and rare diseases in China,&#8221; <a target="_blank" href="https://www.ucb.com/stories-media/Press-Releases/article/UCB-to-Accelerate-Innovation-and-Strategic-Partnerships-Divesting-Mature-Product-Portfolio-in-China" rel="noreferrer noopener">stated</a> Jean-Christophe Tellier, CEO of UCB.
&#8220;The demand for central nervous system products in China has been increasing over the past decade, and by leveraging CBC&#8217;s unique investor-operator approach, we are excited to channel our expertise, resources, and platform synergies to meet these evolving needs and drive value for our stakeholders,&#8221; said Fu Wei, Chief Executive Officer of CBC Group.
The scope of this divestment includes UCB&#8217;s neurology portfolio (Keppra, Vimpat, Neupro) and allergy portfolio (Zyrtec, Xyzal) in Mainland China and UCB&#8217;s Zhuhai manufacturing site.
This transaction will allow UCB to focus its efforts on innovation and partnerships, ensuring that its strategic goals align with the evolving demands of the Chinese market.
Combined net sales for these medicines in China for 2023 were 131 million euros. The transaction is expected to close in the fourth quarter of 2024.
This agreement does not impact UCB&#8217;s financial guidance for 2024. For 2025, a marginal dilution of the adjusted EBITDA margin is anticipated.
The adjusted EBITDA margin for 2025 is expected to remain unchanged at the low end of the range of low to mid-thirties in percent of revenue.
Photo via Shutterstock
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Tuesday,&nbsp;Longboard Pharmaceuticals Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/lbph#NASDAQ">LBPH</a>) released topline data from the PACIFIC Phase 1b/2a study evaluating bexicaserin (LP352) for seizures associated with a broad range of Developmental&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/24/01/36451590/neurology-focused-longboard-pharmaceuticals-stock-soars-over-200-today-heres-why" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">and Epileptic Encephalopathies (DEEs)</a>.
Cantor Fitzgerald&nbsp;writes that the data are among the best reported for seizure meds, with a median 53% reduction in seizures across subtypes (~33% placebo adjusted).
Even though there were just four patients with Dravet Syndrome in the trial, the median seizure reduction achieved with bexicaserin was a remarkable 72%. This level of reduction is comparable to what&nbsp;UCB SA&#39;s&nbsp;(OTC:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/ucbjy#OTC" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">UCBJY</a>) (OTC:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/ucbjf#OTC" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">UCBJF</a>) Fintepla has demonstrated, a bar Cantor initially believed bexicaserin couldn&#39;t reach.
Cantor says &quot;in light of these excellent results&quot; that the price target for LBPH stock has been raised from $35 to $55,&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/quote/LBPH/analyst-ratings" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">with an overweight rating</a>.&nbsp;
Cantor notes that the increased price target might still prove highly conservative since it hasn&#39;t yet reflected the broad &quot;DEE&quot; opportunity in the model.&nbsp;
The analyst awaits additional clarity on that path before incorporating.
The analyst lowered the discount rate from 14% to 12% and factored in less dilutive equity raises, given the stock action.
Cantor analyst notes LBPH remains a top pick - with even higher conviction now that the program is substantially derisked. The analyst sees peak bexicaserin sales of over $1 billion and potentially over $2 billion.
Price Action:&nbsp;LBPH shares are up 222.60% at $19.45 on the last check Tuesday.

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There's Optimism Around Longboard Pharmaceuticals' Anti-Seizure Candidate: Analyst Boosts Price Target

Raymond James&nbsp;initiated coverage on&nbsp;Dianthus Therapeutics Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/dnth#NASDAQ">DNTH</a>), a recent reverse merger with the old Magenta Therapeutics.
The analysts initiate with an Outperform rating and a&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/quote/DNTH/analyst-ratings" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">price target of $24</a>.
The lead asset, DNTH103, is an antibody designed to target active C1s, a key component in the classical pathway, and is protected by intellectual property rights until 2043.
This targeting strategy has been de-risked, especially in light of&nbsp;Sanofi SA&#39;s&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/sny#NASDAQ">SNY</a>) approval of Enjaymo, an antibody targeting total C1s for Cold Agglutinin Disease (CAD). However, DNTH103&#39;s focus on active C1s offers distinct advantages, such as avoiding the protein sink associated with total C1s.
Dianthus is initiating a Phase 2 gMG study with a target product profile that will potentially offer dosing advantages and safety advantages over prevailing comps. Phase 2 data are expected by 2H25. With clear data precedents in gMG, it will be easy to know if DNTH103 is an active and promising drug for gMG. Based on disease biology and PK/PD data, analysts expect DNTH103 to be at least as efficacious as&nbsp;AstraZeneca Plc&#39;s&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/azn#NASDAQ">AZN</a>) Soliris/Ultomiris or&nbsp;Ra Pharmaceuticals, a subsidiary of&nbsp;UCB SA&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/ucbjy#OTC">UCBJY</a>) (OTC: <a class="ticker" href="https://www.benzinga.com/stock/ucbjf#OTC">UCBJF</a>) Zilucoplan.
Dianthus is commencing a Phase 2 study for gMG, with a target product profile with the potential for improved dosing and safety advantages compared to current competitors. Anticipated Phase 2 data results are slated for 2H of 2025. Given the well-established data benchmarks within the gMG field, it will be straightforward to determine if DNTH103 demonstrates active and promising qualities for gMG treatment. Based on our understanding of the disease&#39;s biology and pharmacokinetic/pharmacodynamic data, DNTH103 is expected to exhibit efficacy at least on par with&nbsp;AstraZeneca Plc&#39;s&nbsp;(NASDAQ:&nbsp;AZN) Soliris/Ultomiris or Zilucoplan from&nbsp;Ra Pharmaceuticals, a subsidiary of&nbsp;UCB SA&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/ucbjy#OTC">UCBJY</a>) (OTC: <a class="ticker" href="https://www.benzinga.com/stock/ucbjf#OTC">UCBJF</a>).
Price Action:&nbsp;DNTH shares are up 1.80% at $13.55&nbsp;on the last check Thursday.

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Dianthus' Monoclonal Antibody On Promising Pathway To Gaining The Upper Hand - Analyst

Needham&nbsp;initiated coverage on&nbsp;MoonLake Immunotherapeutics&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mltx#NASDAQ">MLTX</a>) with a Buy rating and&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/quote/MLTX/analyst-ratings" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">a price target of $76</a>.&nbsp;
The analysts&nbsp;Serge Belanger&nbsp;and Rohit Bhasin note the company&#39;s lead product developing sonelokimab (SLK), a dual IL-17A/-17F inhibitor nanobody for chronic dermatological ailments like hidradenitis suppurativa (HS) and psoriasis (PsO), outshining established biologics in terms of efficacy.
The analysts expound that SLK has positioned itself as a potential best-in-class treatment, boasting remarkable efficacy that surpasses that of well-known biologics.&nbsp;
The differentiation comes through its innovative approach of concurrently inhibiting both IL-17A and IL-17F, promising a robust and holistic mode of action.
What further adds to SLK&#39;s allure is its applicability to various indications, offering a collective market opportunity estimated at a substantial $30 billion.&nbsp;
Anticipated growth projections propel this figure even higher, with the market value expected to swell to a noteworthy $40 billion-$50 billion by the mid-2030s.
The analysts emphasize that the upcoming six months hold significant promise for MoonLake Immunotherapeutics. They anticipate a flurry of catalysts and news releases that could drive additional value.&nbsp;
Furthermore, this could amplify the company&#39;s desirability as an acquisition target for major pharmaceutical players deeply invested in these chronic indications,&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/23/07/33244249/moonlakes-potential-sale-stock-price-up-fivefold-since-public-debut-in-2022" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">armed with a biologics portfolio</a>.
Needham sees&nbsp;UCB SA&#39;s&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/ucbjy#OTC">UCBJY</a>) (OTC: <a class="ticker" href="https://www.benzinga.com/stock/ucbjf#OTC">UCBJF</a>) bimekizumab and izokibep by&nbsp;Acelyrin Inc&nbsp;(NASDAQ:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/slrn#NASDAQ" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">SLRN</a>) as the main competitors to SLK.
In late June, SLK demonstrated efficacy results in HS that&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/23/06/33001374/why-moonlake-immunotherapeutics-stock-is-shooting-higher-today" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">appear superior to those of bimekizumab</a>, and izokibep has yet to demonstrate placebo-controlled efficacy results that rival those of SLK or bimekizumab.
Price Action:&nbsp;MLTX shares are down 0.11% at $56.13 on the last check Thursday.

MLTX

SLRN

Skin Disease Focused MoonLake Immunotherapeutics Poised To Outshine Rivals, Analyst Asserts

The FDA approved&nbsp;UCB SA&#39;s&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/ucbjf#OTC">UCBJF</a>) (OTC: <a class="ticker" href="https://www.benzinga.com/stock/ucbjy#OTC">UCBJY</a>) Rystiggo (rozanolixizumab-noli) for generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) or anti-muscle-specific tyrosine&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/23/06/n33019645/ucb-announces-u-s-fda-approval-of-rystiggo-rozanolixizumab-noli-for-the-treatment-of-adults-with-g" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">kinase (MuSK) antibody positive</a>.
The company says Rystiggo is the only FDA-approved treatment in adults for anti-AChR and anti-MuSK antibody-positive gMG, the two most common subtypes of gMG.
The FDA approval is supported by safety and efficacy data from the pivotal Phase 3 MycarinG study. The primary efficacy endpoint was comparing the change from baseline between treatment groups in the MG-ADL total score, a measurement tool that assesses the impact of gMG on the daily functions of 8 signs or symptoms.
A statistically significant difference favoring Rystiggo was observed in the MG-ADL total score change from baseline [-3.4 points in the Rystiggo-treated group at either dose vs. -0.8 points in the placebo-treated group.
Rystiggo will be commercially available in the U.S. during Q3 of 2023.&nbsp;
Last week, the FDA approved&nbsp;Argenx SE&#39;s&nbsp;(NASDAQ:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/argx#NASDAQ" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">ARGX</a>) Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc), an injection for subcutaneous (SC) use for gMG in adult patients who are anti-acetylcholine receptor antibody positive. These patients represent approximately&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/analyst-ratings/analyst-color/23/06/32942320/argenxs-vyvgart-hytrulo-becomes-first-fda-approved-subcutaneous-option-for-generali" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">85% of the total gMG population</a>.

FDA Approves Rystiggo: The Only Treatment for Two Most Common Subtypes of Generalized Myasthenia Gravis in Adults

<ul>
<li>Cantor Fitzgerald&nbsp;has initiated coverage on&nbsp;MoonLake Immunotherapeutics&nbsp;AG&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mltx#NASDAQ">MLTX</a>) with an Overweight rating and a&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/quote/MLTX/analyst-ratings" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">price target of $23</a>.&nbsp;</li>
<li>MoonLake&#39;s lead program Sonelokimab or SLK (IL-17A &amp; IL-17F nanobody), is currently in Phase 2 trials in Hidradenitis Suppurativa (HS-severe skin disease) and Psoriatic Arthritis (PsA).&nbsp;</li>
<li>A more than $5 billion opportunity for SLK in HS is the primary driver of the analyst&#39;s bullish view.&nbsp;</li>
<li>Also See:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/analyst-ratings/analyst-color/22/07/28155579/hc-wainwright-starts-coverage-on-this-best-in-class-agent-for-inflammatory-disorder" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">HC Wainwright Starts Coverage On This &#39;Best-In-Class Agent For Inflammatory Disorders</a>.</li>
<li>After recent positive phase 3 trials from competitor IL-17 injectables,&nbsp;Novartis AG&#39;s&nbsp;(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/nvs#NYSE">NVS</a>)&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/23/02/tr30717197/patients-with-hidradenitis-suppurativa-experienced-sustained-efficacy-and-symptom-improvement-at-" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">Cosentyx</a>&nbsp;and&nbsp;UCB SA&#39;s&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/ucbjy#OTC">UCBJY</a>) (OTC: <a class="ticker" href="https://www.benzinga.com/stock/ucbjf#OTC">UCBJF</a>)&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/22/02/n25695387/health-canada-approves-bimzelx-bimekizumab-for-the-treatment-of-adults-with-moderate-to-severe-pla" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">Bimekizumab</a>&nbsp;raise the analyst&#39;s confidence that SLK will work in HS and will likely raise the efficacy bar.&nbsp;</li>
<li>Approval of IL-17 injectables over the next few years will significantly expand the HS market, and SLK could be a ~$1.5 billion drug.&nbsp;</li>
<li>SLK is also de-risked in PsA. In September, FDA signed off Phase 2 study of sonelokimab for&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/22/09/29010373/fda-clears-moonlakes-nanobody-study-for-arthritis-patients" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">active psoriatic arthritis</a>.&nbsp;</li>
<li>This is a good entry point and timing for buying MLTX shares. The valuation is inexpensive relative to other immunology peers and has a strong catalyst path over the next 12 months.</li>
<li>Price Action:&nbsp;MLTX shares are up 4.79% at $17.08 on the last check Tuesday.</li>
</ul>

Cantor On MoonLake Immunotherapeutics - Initiates On Inexpensive Valuation, Strong Catalyst Path

<ul>
<li>The&nbsp;<a class="editor-rtfLink" href="https://www.prnewswire.com/news-releases/fintepla-fenfluramine-oral-solution-now-fda-approved-for-treatment-of-seizures-associated-with-lennox-gastaut-syndrome-lgs-301511407.html" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">FDA approved</a>&nbsp;UCB SA&#39;s&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/ucbjy#OTC">UCBJY</a>) drug to treat seizures associated with Lennox-Gastaut Syndrome (LGS), a rare form of childhood epilepsy.</li>
<li>The drug, branded as Fintepla, is approved in the U.S. to treat another form of childhood-onset epilepsy, Davet Syndrome (DS), in patients aged two years and older.</li>
<li>LGS causes cognitive dysfunction and frequent seizures.</li>
<li>Developed by Zogenix, Fintepla is available only through a restricted drug distribution program in the U.S.</li>
<li>Related:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/22/01/25103213/ucb-to-buy-epilepsy-focused-zogenix-in-1-9b-deal-see-the-highlights" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">UCB to Buy Epilepsy-Focused Zogenix In $1.9B Deal: See The Highlights</a>.</li>
<li>The FDA approval was supported by safety and efficacy data from a Phase 3 clinical trial in 263 patients with LGS.</li>
<li>Fintepla at a dose of 0.7 mg/kg/day significantly reduced monthly drop seizures frequency by a median of 23.7% from baseline compared to 8.7% placebo.&nbsp;</li>
<li>Nearly a fourth of those patients on FINTEPLA 0.7 mg/kg/day experienced a &ge;50% reduction in drop seizure frequency per 28 days; 18% with &ge;50% to &lt;75% reduction and 6% &ge;75% reduction.</li>
<li>Price Action:&nbsp;UCBJY shares are trading at $59.56 during the market session on the last check Monday.</li>
</ul>

UCB's Rare Childhood Epilepsy Drug Scores FDA Approval

Biogen Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/biib#NASDAQ">BIIB</a>) and&nbsp;Xbrane Biopharma AB&nbsp;have&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/22/02/g25463604/biogen-and-xbrane-announce-commercialization-and-license-agreement-for-proposed-biosimilar-referen" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">entered into a license agreement</a>&nbsp;to develop, manufacture, and commercialize Xcimzane, a preclinical monoclonal antibody, a proposed biosimilar referencing&nbsp;UCB SA&#39;s&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/ucbjy#OTC">UCBJY</a>) Cimzia (certolizumab pegol)
<ul>
<li>Cimzia&#39;s primary indication is for rheumatoid arthritis in adults and axial spondylarthrosis, psoriasis, and Crohn&#39;s disease.&nbsp;</li>
<li>In 2020 global sales of Cimzia were &euro;1.8 billion. Under the agreement terms, Biogen will gain exclusive global regulatory, manufacturing, and commercial rights to Xcimzane.</li>
<li>Biogen will make an upfront payment of $8 million to Xbrane.</li>
<li>Xbrane can receive up to $80 million in potential milestone payments and tiered sales-based royalties.&nbsp;</li>
<li>Xbrane will be responsible for completing the preclinical development of Xcimzane, and Biogen will be responsible for all remaining development activities and costs required to achieve Marketing Authorization in all territories, including clinical development.</li>
<li>Price Action:&nbsp;BIIB shares traded 1.11% lower at $218.85 on Tuesday.</li>
</ul>

Contracts

BIIB

Biogen-Xbrane Enter License Agreement For Cimzia Referenced Biosimilar, Xcimzane

UCB SA&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/ucbjf#OTC">UCBJF</a>)&nbsp;<a class="editor-rtfLink" href="https://www.ucb.com/stories-media/Press-Releases/article/Positive-Top-Line-Results-for-BIMZELXRVbimekizumab-in-Second-Phase-3-Psoriatic-Arthritis-Study" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">posted topline results</a>&nbsp;from the Phase 3 BE COMPLETE study evaluating Bimzelx (bimekizumab) for active psoriatic arthritis patients who were inadequate responders or intolerant to anti-tumor necrosis factor-alpha (anti-TNF-&alpha;) therapy.1&nbsp;
<ul>
<li>The study demonstrated that significantly more patients treated with bimekizumab achieved 50% or greater improvement in signs and symptoms of the disease compared with placebo.</li>
<li>Bimekizumab showed significant improvements over placebo at week 16 in physical function, skin clearance, physical health status, and low disease activity.</li>
<li>Based on these results, UCB plans to submit regulatory applications for bimekizumab in psoriatic arthritis in the U.S. and the European Union in Q3 of 2022.</li>
<li>Related:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/22/01/25103213/ucb-to-buy-epilepsy-focused-zogenix-in-1-9b-deal-see-the-highlights" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">UCB to Buy Epilepsy-Focused Zogenix In $1.9B Deal: See The Highlights</a>.</li>
<li>In the latest study, bimekizumab met the primary and secondary goals in non-radiographic axSpA in Phase 3 Be Mobile 1 study&nbsp;<a class="editor-rtfLink" href="https://www.prnewswire.com/news-releases/positive-top-line-results-for-bimekizumab-in-phase-3-non-radiographic-axial-spondyloarthritis-study-301462807.html" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">disclosed</a>&nbsp;Tuesday.&nbsp;</li>
<li>Bimekizumab led to at least 40% improvement compared to baseline across measurements of disease activity, spinal pain, physical function, and inflammation at week 16.&nbsp;</li>
<li>The results add to the drug&#39;s achievement of primary and secondary goals in&nbsp;<a class="editor-rtfLink" href="https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/positive-top-line-results-bimekizumab-phase-3-ankylosing" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">another phase 3</a>&nbsp;study called Be Mobile 2.&nbsp;</li>
<li>The drug also beat out placebo at other disease activity measurements, partial remission, and nighttime pain.&nbsp;</li>
<li>Price Action:&nbsp;UCBJY shares are up 0.06% at $51.43&nbsp;during the market session on the last check Friday.</li>
</ul>

UCB's Bispecific Marks Phase 3 Win For Second Psoriatic Arthritis Study

Belgian-based&nbsp;UCB SA&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/ucbjf#OTC">UCBJF</a>) has agreed to buy&nbsp;Zogenix Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/zgnx#NASDAQ">ZGNX</a>), a U.S. maker of drugs to treat seizures and rare diseases, for $1.9 billion, expanding its portfolio to treat epilepsy.
<ul>
<li><a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/22/01/n25101797/ucb-to-acquire-zogenix" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">Investors will get $26 in cash</a>&nbsp;for every Zogenix share, plus a potential $2 per share payment if Zogenix&#39;s Fintepla drug gets regulatory approval for Lennox-Gastaut syndrome by the end of 2023.&nbsp;</li>
<li>The initial payment is 66% higher than Tuesday&#39;s closing price of $15.64.</li>
<li>Lennox-Gastaut syndrome is an orphan disease that causes seizures.&nbsp;</li>
<li>Related:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/21/09/23178444/zogenixs-fintepla-shows-long-term-seizure-frequency-reductions-in-childhood-epilepsy" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">Zogenix&#39;s Fintepla Shows Long-Term Seizure Frequency Reductions In Childhood Epilepsy</a>.</li>
<li>Fintepla has already received regulatory approval in the U.S. and European Union for seizures caused by Dravet syndrome, a rare form of epilepsy.</li>
<li>UCB said it would finance the deal with cash and a new term loan.&nbsp;</li>
<li>In addition to contributing to UCB&#39;s revenue growth after closing, the Zogenix deal is expected to be accretive to UCB&#39;s earnings from 2023 onwards.</li>
<li>Lazard and Barclays are UCB&#39;s financial advisors, while Bank of America Securities and SVB Leerink advised Zogenix.</li>
<li>Price Action:&nbsp;ZGNX shares surged 59.9% at $25.00 during the premarket session on the last check Wednesday.</li>
</ul>

Long Ideas

ZGNX

UCB to Buy Epilepsy-Focused Zogenix In $1.9B Deal: See The Highlights

<ul>
<li>The&nbsp;<a class="editor-rtfLink" href="https://www.ucb.com/stories-media/Press-Releases/article/UCB-Announces-European-Commission-Approval-of-BIMZELX-bimekizumab-for-the-Treatment-of-Adults-with-Moderate-to-Severe-Plaque-Psoriasis" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">European Commission has cleared</a>&nbsp;UCB&#39;s&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/ucbjf#OTC">UCBJF</a>) Bimzelx (bimekizumab) for moderate to severe plaque psoriasis in adults.</li>
<li>UCB&#39;s confidence lies in head-to-head studies that pitted Bimzelx against&nbsp;Novartis AG&#39;s&nbsp;(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/nvs#NYSE">NVS</a>) Cosentyx (secukinumab) and found that it was better at achieving complete clearance of skin lesions at both 16 and 48 weeks.</li>
<li>Bimekizumab is approved at a recommended dose of 320 mg, administered by two subcutaneous injections every four weeks to week 16 and every eight weeks after that.</li>
<li>Bimzelx has already been&nbsp;<a class="editor-rtfLink" href="https://www.nice.org.uk/guidance/gid-ta10649/documents/final-appraisal-determination-document" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">pre-approved for NHS reimbursement</a>&nbsp;by NICE. Its costs are likely &quot;similar or lower&quot; than Cosentyx and other biologics used for psoriasis.</li>
<li>Related content:&nbsp;Benzinga&#39;s Full&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/calendars/fda#historical" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">FDA Calendar</a></li>
<li>Price Action:&nbsp;UCBJF shares are up 9.07% at $114.95 during the market session on the last check Wednesday.</li>
</ul>

UCB Gets EU Approval For Bimekizumab In Psoriasis

Ra Pharmaceuticals Inc (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/rarx#NASDAQ">RARX</a>) shares were up 100% Thursday following the announcement of a buyout by Belgian biopharma UCB SA (OTC: <a class="ticker" href="https://www.benzinga.com/stock/ucbjf#OTC">UCBJF</a>).&nbsp;
<h3>The Deal Terms</h3>
Ra Pharm is&nbsp;a clinical-stage biopharma&nbsp;engaged in the development of therapies for serious diseases caused by excessive activation of the complement system, a&nbsp;critical component of the innate immune system.
UCB is paying $48 per share in cash for the company, or $2.5 billion. Net of Ra Pharma&#39;s cash, the transaction is valued at $2.1 billion.
The per share transaction value represented a 93% premium to the 30-day volume weighted average closing price of Ra Pharma shares prior to the signing of the agreement.
The boards of both companies have approved the transaction, according to the announcement.&nbsp;
The closing of the transaction &mdash;&nbsp;which is subject to Ra Pharma shareholder approval, antitrust clearance and other customary closing conditions &mdash;&nbsp;is expected by the end of the first quarter of 2020.
UCB said it will finance the purchase with a combination of existing cash resources and new bank term loans&nbsp;arranged by BNP Paribas, Fortis and Bank of America&nbsp;Merrill Lynch.
<h3>The Deal Logic</h3>
Ra Pharma&#39;s lead product candidate zilucoplan is being evaluated in multiple trials and in preclinical studies for indications such as generalized myasthenia gravis (Phase 3), immune-mediated necrotizing myopathy&nbsp;(Phase 1), amyotrophic lateral sclerosis (Phase 2)&nbsp;and renal disorders (Phase 1).
UCB sees the proposed acquisition as a part of its strategic growth plan.
The addition of Ra Pharma&#39;s Phase 3 asset <a href="https://www.benzinga.com/general/biotech/18/12/12823603/ra-pharma-shares-rally-what-you-need-to-know"> zilucoplan </a> to UCB&#39;s anti-FcRn rozanolixizumab, according to the companies, creates an opportunity to give better treatment options to&nbsp;people living with myasthenia gravis.
The Ra Pharma deal enables UCB to offer new treatment opportunities for several rare diseases in neurology and immunology as well as different delivery forms, including extended release and orally available products.&nbsp;
UCB said the deal will strengthen its presence in the U.S., especially in the innovation hub of Boston, Massachusetts.
From a financial perspective, the deal is expected to be dilutive to UCB&#39;s mid-term earnings due to R&amp;D investments.
The deal will be accretive to core EPS from 2024 onwards, leading to accelerated top- and bottom-line growth from 2024 onwards, the companies said.&nbsp;
Zilucoplan is a rival drug in development to Alexion Pharmaceuticals, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/alxn#NASDAQ">ALXN</a>)&#39;s Soliris, which was approved in October&nbsp;2017 for generalized myasthenia gravis.
Ra Pharma shares were up 100.4% to $45.40 at the time of publication.&nbsp;
Related Links:
<a href="https://www.benzinga.com/general/biotech/19/10/14573015/the-daily-biotech-pulse-ucb-to-buy-ra-pharma-reata-reacquires-rights-to-nrf2-activators-from-abbv">The Daily Biotech Pulse: UCB To Buy Ra Pharma, Reata Reacquires Rights To Nrf2 Activators From AbbVie, BioNTech IPO </a>
<a href="https://www.benzinga.com/analyst-ratings/analyst-color/19/10/14568293/vericel-analyst-projects-wound-care-product-sales-will-grow-fivefold-by-2025">Vericel Analyst Projects Wound Care Product Sales Will Grow Fivefold By 2025 </a>

ALXN

RARX

Ra Pharma Stock Doubles On $2.5B Buyout Deal With Belgian Biopharma UCB

Amgen (NASDAQ:<a class="ticker" href="/stock/AMGN#NASDAQ">AMGN</a>) and UCB (OTC:<a class="ticker" href="/stock/UCBJF#OTC">UCBJF</a>) today announced the resubmission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for EVENITY&trade;* (romosozumab), an investigational monoclonal antibody for the treatment of osteoporosis in postmenopausal women at high risk for fracture. EVENITY increases bone formation and reduces bone resorption simultaneously to increase bone mineral density (BMD) and reduce the risk of fracture.
&quot;A fracture due to osteoporosis can be a life-altering event, and EVENITY has the potential to reduce fracture risk in patients at high risk due to a prior fracture,&quot; said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. &quot;We look forward to continuing our work with the FDA to demonstrate the benefit:risk profile for EVENITY. Our hope is to bring to patients an innovative treatment option that addresses a serious unmet medical need.&quot;
The BLA for EVENITY now adds results from two more recent pivotal Phase 3 trials: the ARCH study, an alendronate-active comparator trial including 4,093 postmenopausal women with osteoporosis who experienced a fracture, and the BRIDGE study, including 245 men with osteoporosis. The FDA will evaluate the clinical benefit:risk profile of EVENITY, including the cardiovascular safety signal seen in the ARCH study, for the potential to reduce the risk of fractures and increase BMD in postmenopausal women with osteoporosis. The original FDA submission included data from a comprehensive Phase 1 and Phase 2 program and the Phase 3 placebo-controlled FRAME study, including 7,180 postmenopausal women with osteoporosis.
&quot;The burden of osteoporosis can have tremendous impact on a patient&#39;s life,&quot; said Pascale Richetta, M.D., head of bone and executive vice president at UCB. &quot;We are one step closer in our ability to bring this first of its kind treatment to thousands of women affected by fragility fractures each year.&quot;
In the U.S., one in two women over the age of 50 will suffer a fragility (or osteoporotic) fracture due to osteoporosis, and with an aging population these numbers will likely rise.1 Yet despite this, there is currently a large gap in the management and treatment of osteoporosis, especially in the post-fracture setting, with an estimated four out of five patients remaining undiagnosed and untreated after a fracture.2 Without proper care or access to effective intervention options, they remain at risk of painful and disabling fractures in the future.
The European Medicines Agency (EMA) and the Pharmaceuticals and Medical Device Agency (PMDA) in Japan are currently reviewing marketing applications for EVENITY and interactions with the agencies are ongoing.

AMGN

Amgen, UCB Resubmit BLA for EVENITY to FDA

<div>
	Amgen (NASDAQ: <a class="ticker" href="/stock/amgn#NASDAQ">AMGN</a>) and UCB (OTC: <a class="ticker" href="/stock/ucbjf#OTC">UCBJF</a>) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for the Biologics License Application (BLA) for EVENITY&trade;* (romosozumab) as a treatment for postmenopausal women with osteoporosis.</div>
<div>
	&nbsp;</div>
<div>
	The original submission included data from the pivotal Phase 3 placebo-controlled FRAME study of postmenopausal women with osteoporosis. With the availability of data from the Phase 3 active-comparator ARCH study, the Agency has asked that the efficacy and safety data from the study be integrated into the application. The resubmission will also include the efficacy and safety data from the BRIDGE study, the Phase 3 trial evaluating EVENITY in men with osteoporosis, which has also been requested. This request will be addressed in the form of a resubmission, which is an extension of the current review.</div>
<div>
	&nbsp;</div>
<div>
	&quot;During our interactions with the FDA, we agreed that the ARCH data should be considered in the regulatory review prior to the initial marketing authorization and, as a result, anticipated this request. We look forward to working through the review process with the Agency,&quot; said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. &quot;We remain committed to helping patients with osteoporosis and will use the additional time to better understand the benefit:risk profile of EVENITY.&quot;</div>
<div>
	&nbsp;</div>
<div>
	&quot;The reality is that once a woman has a fragility fracture, she is five times more likely to suffer another within a year. This is a stark reminder that there is an urgent need to improve post-fracture care and reduce the risk of painful, disabling fractures in the future,&quot; said Dr. Pascale Richetta, head of bone and executive vice president, UCB. &quot;With all three pivotal romosozumab Phase 3 studies now included in the clinical evidence package, representing data from more than 11,000 patients, we are committed to bringing this important potential new treatment to those people living at risk of fragility fractures.&quot;</div>

Amgen, UCB Announce FDA Provides CRL for BLA for EVENITY

Amgen (NASDAQ: <a class="ticker" href="/stock/amgn#NASDAQ">AMGN</a>) and UCB (OTC: <a class="ticker" href="/stock/ucbjf#OTC">UCBJF</a>) today announced results from the fourth year of a Phase 2 study showing the efficacy and safety of a second course of treatment with EVENITY&trade;* (romosozumab), an investigational agent for postmenopausal women with osteoporosis. The results were presented in an oral session (OR08-1) at ENDO 2017, the Endocrine Society&#39;s Annual Meeting in Orlando, Fla.
In the study, postmenopausal women with low bone mass (lumbar spine, total hip or femoral neck T score between -2.0 and -3.5) were initially randomized to various doses of EVENITY or placebo for 24 months and then re-randomized to receive denosumab (Prolia&reg;) or placebo for the next 12 months (24 to 36 months), as previously reported. For months 36 to 48, all of these patients were then treated with EVENITY (210 mg) for 12 months.
In patients who initially received 210 mg of EVENITY followed by placebo and then a second course of EVENITY (n=19), the second course led to significant increases in bone mineral density (BMD) to an extent similar to the initial EVENITY treatment: lumbar spine (12.7 percent), total hip (5.8 percent) and femoral neck (6.3 percent) during months 36 to 48. In those patients who received a second course of EVENITY after denosumab, EVENITY further increased BMD by 2.8 percent at the lumbar spine, while maintaining BMD at the total hip and femoral neck.
&quot;Since osteoporosis is a chronic condition, which may lead to debilitating fractures, the option of providing a second course of bone-building therapy may benefit some patients with severe osteoporosis,&quot; said David L. Kendler, M.D., University of British Columbia, Vancouver, Canada and lead study investigator. &quot;This latest study is important as it shows that the safety and efficacy of romosozumab extends from initial use to a second course of treatment.&quot;
A similar adverse event (AE) profile was observed in the EVENITY groups, regardless of prior treatment group (placebo or denosumab). In patients treated with EVENITY for months 36 to 48, serious AEs were reported for five percent of patients who initially received EVENITY (n=7/140) and four percent who initially received placebo (n=1/27). The AEs reported by these patients for months 36 to 48 include hypersensitivity (7.4 percent, initial placebo; 7.9 percent, initial EVENITY), injection-site reactions (7.4 percent, initial placebo; 7.1 percent, initial EVENITY), malignancies (3.7 percent, initial placebo; 3.6 percent, initial EVENITY) and osteoarthritis (11.1 percent, initial placebo; 2.1 percent, initial EVENITY). There were no reports of osteonecrosis of the jaw or atypical femoral fracture.
In the same oral session, Amgen and UCB presented results from a separate analysis of the Phase 2 study (OR08-2) showing BMD gains from prior EVENITY treatment were generally maintained for two years (months 48 to 72) when followed by a single dose of zoledronic acid.
The pivotal romosozumab Phase 3 studies have all been designed with patients receiving 12 months (single course) of romosozumab followed by treatment with an anti-resorptive therapy such as denosumab.

Amgen, UCB Report New Data Examining The Option Of A Second Course Of Treatment With EVENITY at ENDO 2017

UCB (OTC: <a class="ticker" href="/stock/ucbjf#OTC">UCBJF</a>) and Dermira, Inc. (NASDAQ: <a class="ticker" href="/stock/derm#NASDAQ">DERM</a>) today announced key results from CIMPACT, a Phase 3, multi-center, placebo-controlled and active-controlled clinical trial evaluating the efficacy and safety of CIMZIA&reg; (certolizumab pegol) in adult patients with moderate-to-severe chronic plaque psoriasis. In the CIMPACT trial, CIMZIA demonstrated statistically significant improvements for the primary endpoint. CIMPACT is the third and final Phase 3 clinical trial evaluating CIMZIA in this patient population.1 Based on the results of the CIMPACT trial, and those from the previously reported CIMPASI-1 and CIMPASI-2 trials, UCB intends to submit marketing applications to regulatory authorities in the third quarter of 2017. CIMZIA is not currently approved for the treatment of psoriasis by any regulatory authority worldwide.

	&nbsp;

	The primary endpoint in CIMPACT assessed the percentage of patients on CIMZIA who achieved a 75% or greater disease improvement from baseline as measured by the Psoriasis Area and Severity Index (PASI 75), compared with placebo, at week 12. Several secondary endpoints were assessed, including comparisons of the efficacy of CIMZIA to ENBREL&reg; based on PASI 75 response rates at week 12 and comparisons of the response rates of CIMZIA-treated patients to placebo-treated patients at week 16 using (1) PASI 75 and (2) at least a two-point improvement on a five-point Physician&#39;s Global Assessment (PGA) scale to a final score representing clear or almost clear skin. In both the CIMPASI-1 and CIMPASI-2 trials, PASI 75 and PGA were co-primary endpoints assessed at week 16.

	&nbsp;

	&quot;We are pleased that the CIMPACT results are consistent with the efficacy and safety findings observed in two earlier trials evaluating CIMZIA in patients with moderate-to-severe plaque psoriasis,&quot; said Tom Wiggans, chief executive officer of Dermira. &quot;Both companies look forward to submitting these data to regulatory authorities to support a potential approval of CIMZIA as a treatment option for moderate-to-severe chronic plaque psoriasis.&quot;

	&nbsp;

	&quot;The results from CIMPACT support our belief that CIMZIA may one day be an important treatment option for patients living with psoriasis. Our psoriasis clinical development program, and our collaboration with Dermira, aims to provide value to this important patient population and broaden access to CIMZIA, the only Fc-free, PEGylated anti-TNF,&quot; said Emmanuel Caeymaex, Head of Immunology and Executive Vice President, Immunology Patient Value Unit, UCB. &quot;We look forward to sharing additional data from all three trials at an upcoming medical congress.&quot;

	&nbsp;

	In all three CIMZIA Phase 3 clinical trials, CIMZIA demonstrated statistically significant improvements for all primary or co-primary endpoints compared to placebo at both treatment doses.

DERM

Dermira Announces Final CIMZIA Phase 3 Trial Meets Primary Efficacy Endpoint in Patients with Moderate-to-Severe Chronic Plaque Psoriasis

FDA Approves Briviact to Treat Partial Onset Seizures

The American healthcare system became much more affordable with the advent of generic drugs. Many popular medications have lower-costing, alternative treatments that contain the same active ingredients as their costly brand-name rivals, which has saved the public millions in pharmaceutical costs.
 However, <a href="http://www.wsj.com/articles/mallinckrodt-says-fda-reclassified-adhd-generic-drug-1415888276">last year</a> the U.S. Food and Drug Administration took a look at some generic treatments for attention deficit hyperactivity disorder (ADHD) and found that they weren't consistently providing the same results as the brand name drug, leading the FDA to reclassify the generics.
<h3>What Happened?</h3>

Last year, generic equivalents of Johnson &amp; Johnson (NYSE: <a class="ticker" href="/stock/jnj#NYSE">JNJ</a>)&#39; ADHD treatment Concerta made by Mallinckrodt PLC (NYSE: <a class="ticker" href="/stock/mnk#NYSE">MNK</a>) and UCB S A (OTC: <a class="ticker" href="/stock/ucbjf#OTC">UCBJF</a>) were shown to have a different impact on a patient's body despite containing the same active ingredients. Because of this, the FDA changed those drugs' ratings to reflect its findings.

Following the ratings change, the FDA gave each drug maker a period of six weeks to prove that their drugs were in fact equivalent to Concerta. If they could not be proven as equal, the companies were asked to voluntarily pull the drugs from the marketplace.
<bzrelatedlink>Related Link: <a href="http://www.benzinga.com/general/biotech/15/05/5504748/5-new-biotech-developments-worth-watching">5 New Biotech Developments Worth Watching</a></bzrelatedlink>
<h3>Mallinckrodt Pushes Back</h3>

This week that six month deadline passed, but with very little movement from Mallinckrodt. UCB officials say they have been working to meet FDA requirements, but Mallinckrodt CEO Mark Trudeau <a href="http://www.wsj.com/articles/can-fda-reclassify-generic-drugs-1431658337">said</a> the company has no plans to remove its drug from pharmacy shelves.
 Instead, Mallinckrodt filed a lawsuit challenging the FDA ruling that the drugs were not equivalent, saying that the agency encouraged patients to continue taking the generic ADHD medications if they weren't experiencing any issues.
<h3>Loss Of Trust</h3>
Only time will tell whether or not Mallinckrodt will be forced to make changes to its drug, but the challenge sets up an obstacle for all generic companies providing treatments in the U.S.
While the FDA's inquiry into the effectiveness of the two drugs reflects the agency's role in protecting the public, some say the results are likely to diminish people's trust in the generic drug market. This is especially true as both of the two drugs deemed inadequate substitutes for Concerta are still being sold as a generic version in pharmacies across the country.
Image Credit: <a href="http://pixabay.com/en/pharmacy-medicine-food-supplement-218692/">Public Domain</a>

The FDA's Authority Challenged By Mallinckrodt

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