The Daily Biotech Pulse: Regeneron COVID-19 Antibody Cocktail Data, FDA Nod For Mallinckrodt, Molecular Partners IPO

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

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs June 15)

  • Apellis Pharmaceuticals, Inc. APLS
  • Citius Pharmaceuticals, Inc. CTXR (announced an expansion to its scientific advisory board)
  • Clearside Biomedical, Inc. CLSD (announced positive results for Phase 1/2a wet age-related macular degeneration study)
  • Dicerna Pharmaceuticals, Inc. DRNA
  • Edwards Lifesciences Corporation EW
  • Intra-Cellular Therapies, Inc. ITCI
  • Jazz Pharmaceuticals plc JAZZ
  • LeMaitre Vascular, Inc. LMAT
  • RAPT Therapeutics, Inc. RAPT
  • ResMed Inc. RMD
  • ShockWave Medical, Inc. SWAV
  • Zoetis Inc. ZTS

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows June 15)

  • Achilles Therapeutics plc ACHL
  • Inhibikase Therapeutics, Inc. IKT (reacted to a common stock offering)
  • Janux Therapeutics, Inc. JANX (IPOed Friday)
  • Singular Genomics Systems, Inc. OMIC
  • Spruce Biosciences, Inc. SPRB
  • Terns Pharmaceuticals, Inc. TERN
  • Vertex Pharmaceuticals Incorporated VRTX

Stocks In Focus

Aptinyx to Initiate Phase 2b Study of Post-traumatic Stress Disorder Drug, Discloses Statistical Error In Previously Reported Phase 1 Data

Aptinyx Inc. APTX announced that it has finalized the design of its Phase 2b program for NYX-783 in patients with post-traumatic stress disorder after having received the minutes from its recent Type C meeting with the FDA.

The company expects to initiate the Phase 2b program in the fourth quarter of 2021.

Aptinyx also announced that, in its preparation for Phase 2b, it identified a statistical error made by the contract research organization that performed the statistical analysis of the previously completed exploratory Phase 2 study in PTSD. Accordingly, the company is providing updated statistical analysis for the exploratory Phase 2 study, which has no impact on the study conclusions.

The revised mixed model for repeated measures p-values are higher than previously reported in October 2020. The CRO confirmed the error in late May and reported the updated statistical analysis to the company in June.

The stock slipped 9.74% to $3.15 in after-hours trading.

Regeneron's Antibody Cocktail Found Effective Against Hospitalized Severe COVID-19 Patients In a Large U.K. Study

Regeneron Pharmaceuticals, Inc. REGN announced positive results from the largest trial assessing any monoclonal antibody treatment in patients hospitalized with severe COVID-19.

The UK RECOVERY trial found that adding investigational REGEN-COV to usual care reduced the risk of death by 20% in patients who had not mounted a natural antibody response on their own against SARS-CoV-2, compared to usual care on its own.

"There was great uncertainty about the value of antiviral therapies in late-stage COVID-19 disease. It is wonderful to learn that even in advanced COVID-19 disease, targeting the virus can reduce mortality in patients who have failed to mount an antibody response of their own," said Sir Peter Horby, joint chief investigator for the RECOVERY trial.

Regeneron said it is in discussions with the FDA to expand the current emergency use authorization to other populations, including the prevention and hospitalized patient settings. The company expects to submit a full biologics license application for REGEN-COV this summer.

FDA Approves Mallinckrodt's Thermal Burn Treatment

Mallinckrodt plc MNKKQ said the FDA has approved StrataGraft, its allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen – dsat, for the treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated.

Eton In-licenses Rescue Medication For Adrenal Crisis

Eton Pharmaceuticals, Inc ETON said it has acquired U.S. and Canadian rights to Crossject's Zeneo hydrocortisone needleless autoinjector, which is under development as a rescue treatment for adrenal crisis.

Eton said it expects to submit a new drug application for the product to the FDA in 2023 and plans to request orphan drug designation.

Under the terms of the agreement, Crossject will receive development and regulatory milestone payments from Eton of up to $5 million, commercial milestones of up to $6 million, and a 10% royalty on net sales of the product. Crossject will be responsible for the management and expense of development, clinical, and manufacturing activities. Eton will be responsible for all regulatory and commercial activities.

The stock was up 2.34% at $6.99 in after-hours trading.

Related Link: Attention Biotech Investors: Mark Your Calendar For June PDUFA Dates

United Therapeutics' Pulmonary Arterial Hypertension Drug Regulatory Application Accepted For Priority Review

United Therapeutics Corporation UTHR announced that the FDA accepted for priority review the NDA for Tyvaso DPI (inhaled treprostinil) for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.

The company expects the agency's review to be complete in October. FDA also indicated that they have not identified any potential review issues at this time.

Epizyme, Quest Launch Follicular Lymphoma Diagnostic Test

Epizyme, Inc. EPZM announced the launch of the EZH2Now Testing Program, an Epizyme initiative in collaboration with Quest Diagnostics DGX to provide EZH2 mutation testing for patients with relapsed or refractory follicular lymphoma.

In premarket trading Wednesday, Epizyme shares were up 5.13% to $9.23.

Biocryst Announces Acceptance of Regulatory Application For Hereditary Angioedema Drug In Israel

BioCryst Pharmaceuticals, Inc. BCRX said the Israeli Ministry of Health has accepted the regulatory submission of Orladeyo for the prevention of recurrent attacks in patients with hereditary angioedema, 12 years and older. The Israeli Ministry of Health also has granted an accelerated review.

Altimmune Reports Positive Phase 1 Data For Weight Loss Drug

Altimmune, Inc. ALT announced results from a prespecified 6-week interim analysis of its ongoing 12-week, Phase 1, study of ALT-801 in healthy overweight and obese volunteers, with the interim data showing a mean weight loss of 5.4% was achieved by Week 6 with a once weekly ALT-801 dose of 1.8 mg administered subcutaneously compared to a weight gain of 0.9% in the placebo group.

This surpassed the pre-established treatment target of 2% weight loss. ALT-801 was also well-tolerated, the company added.
The stock was gaining 4.74% to $14.80 in premarket trading.

AVITA Raises Q4 Guidance

AVITA Medical, Inc. RCEL preannounced results for the fiscal quarter ending June 30, 2021, with revenues realized to-date exceeding the company's guidance range of $8.2 million to $8.6 million.

Based on the strength of both Recell commercial revenue and BARDA related revenue, the company raised its fiscal fourth-quarter guidance to be in the range of $9.5 - $9.7 million.

In after-hours, the stock rallied 15.6% to $22.10.

Catabasis Jumps On Disclosure of Institutional Stake

Catabasis Pharmaceuticals, Inc. CATB rallied after the company said in a filing with the SEC RA Capital Management, L.P has a 7.5% stake in the company.

The stock jumped 29.90% to $2.65 in after-hours trading.

Atara Advances On Insider Buying

Atara Biotherapeutics, Inc. ATRA shares moved higher after a SEC filing revealed Kristin Yarema, its chief commercial officer, bought 34,354 shares in the company, priced between $14.48 and $14.58.

In after-hours trading, the stock was up 3.93% at $14.55.

On The Radar

PDUFA Date

Blueprint Medicines Corporation BPMC has a decision date of Wednesday for its supplemental NDA for Ayvakit as a treatment option for advanced systemic mastocytosis.

Earnings

Centogene N.V.CNTG

IPO

Swiss biopharma Molecular Partners AG priced its initial public offering of 3 million ADSs at $21.25 per ADS, for total gross proceeds of approximately $63.8 million. Each ADS represent the right to receive one common share.

The company had earlier given an indicative price of $27.14 per ADS, going by the 24.40 Swiss franc per share price at which its Swiss exchange listed shares closed June 8.

The ADSs of the biopharma that focuses on infectious disease, oncology and ophthalmology are expected to trade on the Nasdaq under the symbol "MOLN."

Posted In: BiotechEarningsNewsPenny StocksSmall CapFDAIPOsTop StoriesPre-Market OutlookGeneral

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