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The Daily Biotech Pulse: Amarin Faces Legal Setback, Milestone Payment Kicks In For CytomX, Savara, Reata Disclose COVID-19 Disruptions

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The Daily Biotech Pulse: Amarin Faces Legal Setback, Milestone Payment Kicks In For CytomX, Savara, Reata Disclose COVID-19 Disruptions

Here's a roundup of top developments in the biotech space over the last 24 hours:

Scaling The Peaks

(Biotech stocks that hit 52-week highs March 30.)

  • Athersys Inc (NASDAQ: ATHX) (reacted to $7-million capital injection by Japanese partner)
  • Quidel Corporation (NASDAQ: QDEL)

Down In The Dumps

(Biotech stocks that hit 52-week lows March 26.)

  • Gritstone Oncology Inc (NASDAQ: GRTS)
  • Opko Health Inc. (NASDAQ: OPK)
  • Second Sight Medical Products Inc (NASDAQ: EYES) (announced winding down of operations in the wake of COVID-19 pandemic)
  • Trevi Therapeutics Inc (NASDAQ: TRVI)

Stocks In Focus

Court Rules Against Amarin In Vascepa Litigation

Amarin Corporation plc (NASDAQ: AMRN) shares came under pressure after the U.S. District Court for the District of Nevada ruled in favor of two generic companies in the patent litigation brought by Amarin related to its Vascepa capsule franchise.

Amarin said the two companies have filed ANDAs — regulatory filings for approval of a generic drug — with the FDA for Vascepa. 

Amarin said it disagrees with the ruling and will pursue all available remedies, including appealing the decision and seeking a preliminary injunction pending appeal, if the ANDAs submitted by the two companies are approved by the FDA.

The stock was down 69.66% at $4.12 in Tuesday's premarket session. 

CytomX Pockets $40M Milestone Payment For Cancer Drug

CytomX Therapeutics Inc (NASDAQ: CTMX) said it achieved a clinical milestone related to its CX-2029, a prodrug drug conjugate against CD71, a cell surface protein essential for iron uptake in dividing cells. The milestone relates to achievement of pre-specified criteria for the dose escalation phase of the ongoing Phase 1/2 study, and this has kicked in $40 million in milestone payments to CytomX.

CytomX is co-developing CX-2029 with AbbVie Inc (NYSE: ABBV) following a 2016 licensing agreement.

"CD71 is highly expressed in a number of solid and hematologic cancers and has attractive molecular properties for efficient delivery of cytotoxic payloads to tumor cells," CytomX said.

Issuing a clinical update in light of the COVID-19 pandemic, CytomX said it has decided to temporarily pause new patient enrollment and new site activation in the study evaluating CX-2009 and has also opted to terminate the study evaluating the anti-PD-L1 Probody CX-072 in combination with Bristol-Myers Squibb Co's (NYSE: BMY) Yervoy in melanoma.

CytomX shares were trading 6.72% to $7.15 in Tuesday's premarket session. 

See also: The Week Ahead In Biotech: Clinical Readouts, COVID-19 News Flow In Focus Amid Continuing Uncertainty

Esperion Commercially Launches Non-Statin LDL-Cholesterol Lowering Drug

Esperion Therapeutics Inc (NASDAQ: ESPR) announced commercial availability of its bempedoic acid (brand name Nexletol) tablet, indicated for lowering LDL-cholesterol, in the U.S.

The company said the tablet is now available at a list price of around $10 per day to payers.

The stock was adding 1.53% to $34.50 in premarket trading Tuesday.

Reata Stops Late-Stage Study Of Lead Drug In Hypertension Due To COVID-19 Risk

Reata Pharmaceuticals Inc (NASDAQ: RETA) said it has decided, in consultation with Data Safety Monitoring Board, to stop its Phase 3 CATALYST study due to the risk of severe adverse outcomes associated with COVID-19 among patients with respiratory and autoimmune diseases.

The study was evaluating its bardoxolone methyl in patients with connective tissue disease-associated pulmonary arterial hypertension. The company said the decision is not due to any safety issues with the investigational asset.

Reata said it will also close the RANGER study, an open-label extension study of bardoxolone in patients with PAH. It also temporarily paused enrollment of new patients in the Phase 3 FALCON trial in patients with autosomal dominant polycystic kidney disease.

The stock was sliding 9.81% to $146 in premarket trading Tuesday.

Savara Stops Enrollment In 2 Cystic Fibrosis Studies

Savara Inc (NASDAQ: SVRA) said it is has terminated enrollments into two studies, ENCORE and AVAIL, citing patient safety amid the COVID-19 pandemic.

AVAIL is a Phase 3 study evaluating AeroVanc in cystic fibrosis patients, who have methicillin-resistant Staphylococcus aureus lung infection, while ENCORE is a Phase 2a study evaluating Molgradex in nontuberculous mycobacterial lung infection in CF patients

In premarket trading Tuesday, Savara shares were moving down 7.66% to $2.17.

Akero Reports Positive Midstage Results For NASH Drug

Akero Therapeutics Inc (NASDAQ: AKRO) announced positive results for the Phase 2a BALANCED study that evaluated three doses of investigational non-alcoholic steatohepatitis, or NASH, therapy AKR-001. The company noted that for all the three doses, the study met the primary endpoint of absolute change from baseline in liver fat as measured by magnetic resonance imaging – proton density fat fraction at week 12.

The company said it will report top-line safety/tolerability, lab measures and paired biopsy data from the study in the second quarter.

Akero, however, said it is delaying the planned initiation of the BALANCED study cohort C in NASH patients who have compensated cirrhosis, Child-Pugh Class A. 

Verona Pharma's Inhaled Ensifentrine Found Efficacious In Midstage COPD Study

VERONA PHARMA P/S ADR (NASDAQ: VRNA) announced positive efficacy and safety data with a single dose of pressurized metered-dose inhaler formulation of ensifentrine in a Phase 2 study in patients with moderate to severe chronic obstructive pulmonary disease.

The company noted that data from the single dose part (Part A) of the study demonstrated a statistically significant and clinically meaningful increase in lung function as measured by forced expiratory volume in one second compared to placebo.

Lily Announces Licensing Agreement For Immunometabolic Drugs

Eli Lilly And Co (NYSE: LLY) announced a licensing and collaboration agreement with privately held Sitryx to discover and develop immunometabolic medicines. The collaboration will study up to four novel preclinical targets identified by Sitryx that could lead to potential new medicines for autoimmune diseases.

Sitryx stands to receive a $50-million upfront payment and also a $10-million equity investment from Lilly. The former is also eligible to receive potential development milestones up to $820 million, as well as commercialization milestones and royalty payments on potential sales in the mid- to high-single digit range.

In premarket trading Tuesday, Lilly shares were down 1.76% at $136. 

Iterum To Delay Late-Stage Readout Of Urinary Tract Infection Drug

Iterum Therapeutics PLC (NASDAQ: ITRM) announced a delay in the release of top-line data from the pivotal Phase 3 studies of sulopenem in complicated urinary tract infection and uncomplicated urinary tract infection from the first quarter to early second quarter.

Earnings

Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) reported flat fourth-quarter revenue of $1.2 million and a loss of 8 cents per share, narrower than the year-ago loss of 29 cents per share. The loss was in line with expectations.

The company also hinted at a possible delay in the European launch of buprenorphine implant, its novel six-month maintenance treatment for opioid use disorder, as its commercialization partner Molteni is located in Italy.

The stock was seen shedding 9.52% to 25 cents in premarket trading Tuesday.

Alpine Immune Sciences Inc (NASDAQ: ALPN) reported fourth-quarter collaboration revenue of $884,000 in 2019 compared to zero revenue a year ago. The net loss per share narrowed from 80 cents to 33 cents. Analysts estimated a wider loss of 58 cents per share.

In premarket trading, Alpine shares were rallying 22.57% to $3.15. 

On The Radar

Earnings

  • Trinity Biotech plc (NASDAQ: TRIB) (before the market open)
  • I-Mab ADR (NASDAQ: IMAB) (before the market open)
  • China Pharma Holdings, Inc. (NYSE: CPHI) (before the market open)
  • Milestone Scientific Inc. (NYSE: MLSS (before the market open)
  • BioNTech SE – ADR (NASDAQ: BNTX) (time not supplied)

Related Link: COVID-19 Vaccine Updates: J&J Identifies Lead Candidate, IMV Eyes Clinical Testing In Summer, Altimmune Partners With University Of Alabama

 

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