The Daily Biotech Pulse: Adcom Backs Merck's Oral COVID-19 Treatment; Regulatory Setbacks For CTI Biopharma, BioXcel; Favorable Ruling For Viatris In Tecfidera Patent Case

The Daily Biotech Pulse: Adcom Backs Merck's Oral COVID-19 Treatment; Regulatory Setbacks For CTI Biopharma, BioXcel; Favorable Ruling For Viatris In Tecfidera Patent Case

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

Stocks In Focus

Merck Gets Adcom Backing For Oral COVID-19 Antiviral Medication Molnupiravir

The Food and Drug Administration's Antimicrobial Drugs Advisory Committee on Tuesday recommended giving emergency use authorization for molnupiravir, an oral COVID-19 pill developed by Merck & Co., Inc. MRK and its partner Ridgeback Biotherapeutics.

The Adcom voted 13-10 that the known and potential benefits of molnupiravir outweigh its known and potential risks for the treatment of mild to moderate COVID-19 in high-risk adult patients who are within five days of symptom onset.

Merck's shares were up 5.74% at $79.21 in premarket trading.

CTI Biopharma's Blood Cancer Drug Review Extended By 3 Months

CTI BioPharma Corp. CTIC said the FDA has extended the review period for the new drug application for pacritinib for the treatment of adult patients with intermediate or high-risk primary or secondary myelofibrosis with a baseline platelet count of less than 50 × 109/L.

The additional time sought is for reviewing the additional clinical data the company submitted to the FDA upon its request.

The new PDUFA goal date has been fixed for Feb. 28, 2022.

The stock was sliding 12.89% to $1.96 in premarket trading.

Sanofi To Buy Acne Vaccine Developer Origimm, Reaffirms Midterm Vaccine Sales Growth Guidance

Sanofi SNY announced an agreement to acquire Origimm Biotechnology, an Austrian privately owned biotechnology company specializing in the discovery of virulent skin microbiome components and antigens from bacteria causing skin disease such as acne.

The transaction will add ORI-001, a therapeutic vaccine candidate for acne vulgaris based on recombinant proteins, which entered preliminary clinical studies in the third quarter.

Separately, at a hybrid Vaccines Investor Event hosted by Sanofi, the company confirmed its mid-term sales guidance announced at the 2019 Capital Markets Day of mid-to-high single-digit growth for its vaccines business.

Appeals Court Rules In Favor Of Viatris In Multiple Sclerosis Drug Patent Case

Viatris, Inc. VTRS announced that the U.S. Court of Appeals for the Federal Circuit affirmed the June 2020 decision by the U.S. District Court for the Northern District of West Virginia invalidating Biogen Inc.'s BIIB Tecfidera patent for the lack of a written description.

Viatris shares were up 2.36% at $12.60 in premarket trading.

Related Link: The Week Ahead In Biotech (Nov. 28-Dec. 4): FDA Decisions For VBI Vaccines, BeyondSpring, CTI Biopharma And Merck Take The Spotlight In A Light Calendar Week

Sage, Biogen Say Major Depressive Disorder Treatment Found Safe, Demonstrated Rapid, Sustained Improvements

Sage Therapeutics, Inc. SAGE, and Biogen announced 12-month data for the cohort of major depressive disorder patients who received zuranolone 50 mg once nightly for 14 days as their initial dose in the ongoing Phase 3 study and had the opportunity to be followed for 12 months.

For the primary endpoint of safety and tolerability, the data analyzed to date show zuranolone was generally well-tolerated, with no new safety findings or trends identified in the long-term safety data available regardless of the number of courses of zuranolone a patient received.

About 6.5% of patients discontinuing study drug due to adverse events.

Zuranolone has consistently demonstrated rapid and sustained improvements in depressive symptoms and a well-tolerated safety profile throughout the LANDSCAPE clinical program.

Sage shares were down 2.34% at $38, while Biogen was adding 0.92% at $237.90.

BioXcel Says PDUFA Date For Schizophrenia Drug Extended By 3 Months

BioXcel Therapeutics, Inc. BTAI said the FDA has extended the PDUFA date for its review of the NDA of BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II from Jan. 5, 2022 to April 5, 2022.

The stock was receding 7.59% to $21.19 in premarket trading.

SAB's Flu Treatment Candidate Aces Midstage Study

SAB Biotherapeutics, Inc. SABS said SAB-176, its investigational therapeutic for the treatment of seasonal influenza, achieved statistically significant reductions in viral load and clinical signs and symptoms compared to placebo in a Phase 2a challenge study.

The stock was up 4.59% at $11.39 in premarket trading.

Immunome's Antibody Cocktail Could Be Effective Against Omicron Variant

Immunome, Inc. IMNM said based on structural mapping of omicron's mutations and insights from direct preclinical testing of Alpha, Beta, Gamma and Delta variants, it expects its cocktail — IMM-BCP-01 — to be active against the omicron variant. The company also said it is diligently working to confirm this activity in laboratory testing and expects initial results to be available in January 2022.

The stock was surging 18.58% to $22.47 in premarket trading.

Quidel Says Its U.S.-Made PCR, Rapid Antigen Tests Can Detect COVID-19 Variant

Quidel Corporation QDEL said early data gives it confidence that its U.S.-made PCR and rapid antigen tests can detect COVID-19 caused by the omicron variant.

"Regarding our antigen assays, GISAID analysis shows a high likelihood that the Omicron variant is detectable by our immunoassays. Of course, we are following up these analyses by testing live samples, and Quidel, like our industry peers, will know more in time," said Douglas Bryant, CEO of Quidel.

Offerings

Aditxt, Inc. ADTX announced the launch of an underwritten public offering. The proposed offering of the common stock and warrants is being made pursuant to an effective shelf registration statement on Form S-3 that was previously filed with the SEC and declared effective by the SEC on July 13.

The stock was slipping 19.66% to 94 cents in premarket trading.

ImmunoGen, Inc. IMGN announced it intends to sell $175 million in shares of its common stock in an underwritten public offering. All of the shares of common stock to be sold in the offering are to be offered by ImmunoGen.

MEI Pharma, Inc. MEIP said it plans to offer 17.5 million shares of its common stock in an underwritten public offering.

In premarket trading, the stock was retreating 0.89% to $3.34.

Click here to access Benzinga's FDA Calendar.

On The Radar

Clinical Readouts

180 Life Sciences Corp. ATNF is scheduled to present at the 2021 International Dupuytren Symposium phase 2a clinical trial data to identify the optimal dose and top line data for the recently completed phase 2b clinical trial on efficacy for patients with early-stage disease. (3 p.m.)

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

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