The Daily Biotech Pulse: Pfizer-BioNTech US Vaccine Contract, Summit Slumps On Adverse Regulatory Feedback, Cerevel CFO Departs - iShares Biotechnology ETF (NASDAQ:IBB)

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 Sept. 20)

Acceleron Pharma Inc. XLRN
Aurinia Pharmaceuticals Inc. AUPH
C4 Therapeutics, Inc. CCCC
Cerevel Therapeutics Holdings, Inc. CERE
Corvus Pharmaceuticals, Inc. NASDAQ: CRVS)
Fulcrum Therapeutics, Inc. FULC
IVERIC bio, Inc. ISEE
Leap Therapeutics, Inc. LPTX
Opiant Pharmaceuticals, Inc. OPNT
Repligen Corporation RGEN

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Sept. 20)

Ambrx Biopharma Inc. AMAM
Absci Corporation ABSI
Acutus Medical, Inc. AFIB
Aytu Biopharma, Inc. AYTU
AzurRx BioPharma, Inc. AZRX
Biomea Fusion, Inc. BMEA
Centessa Pharmaceuticals Limited CNTA
Codex DNA, Inc. DNAY
Emergent BioSolutions Inc. EBS
Galapagos NV GLPG
Harpoon Therapeutics, Inc. HARP
InMed Pharmaceuticals Inc. INM
Jazz Pharmaceuticals plc JAZZ
Keros Therapeutics, Inc. KROS
Lixte Biotechnology Holdings, Inc. LIXT
Miromatrix Medical Inc. MIRO
Oncorus, Inc. ONCR
Oyster Point Pharma, Inc. OYST
Pasithea Therapeutics Corp. KTTA (IPOed Sept. 15)
Rallybio Corporation RLYB
Sight Sciences, Inc. SGHT
Singular Genomics Systems, Inc. OMIC
Spruce Biosciences, Inc. SPRB
TCR2 Therapeutics Inc. TCRR
Teligent, Inc. TLGT
TherapeuticsMD, Inc. TXMD
Titan Pharmaceuticals, Inc. TTNP
Verona Pharma plc VRNA
Viveve Medical, Inc. VIVE

Stocks In Focus

bluebird bio Completes Regulatory Filing For Approval of Gene Therapy to Treat Bleeding Disorder

bluebird bio, Inc. BLUE has completed the rolling submission of its biologics license application to the Food and Drug Administration for betibeglogene autotemcel gene therapy in adult, adolescent and pediatric patients with β-thalassemia who require regular red blood cell transfusions, across all genotypes.

If approved, beti-cel will be the first hematopoietic stem cell ex-vivo gene therapy for patients in the U.S.

The stock was up 2.67% to $18.47 in premarket trading.

Click here for accessing Benzinga's FDA Calendar

Summit Says FDA Does Not Approve of Primary Endpoint of Combined Phase 3 Study In Bacterial Infection

Summit Therapeutics Inc. SMMT disclosed in a filing that it has received feedback from the FDA that the regulator does not agree with the change to the primary endpoint that Summit proposed and has subsequently implemented in its ongoing Phase 3 Ri-CoDIFy studies when combining the studies.

The study is intended to compare ridinilazole versus vancomycin for the treatment of clostridium difficile infection.

The company had combined the Phase 3 studies into a single study and will provide the combined results to all stakeholders, as the top line results become available. These top line results will best inform all parties as to the next appropriate course of action regarding ridinilazole. Summit anticipates communicating these results during the first quarter of 2022.

In premarket trading, the stock was retreating 19.75% to $5.20.

Incyte's Opzelura Cream Gets FDA Approval For Treating Eczema

Incyte Corporation INCY announced that the FDA has approved Opzelura cream for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.

Opzelura is the first and only topical formulation of a JAK inhibitor approved in the U.S.

The stock was down 2.46% at $74.19 in premarket trading.

Pfizer-BioNTech to Supply U.S. 500M More COVID-19 Vaccine Doses to be Distributed to Low- and Lower-middle Income Countries

Pfizer PFE and BioNTech SE BNTX announced plans to expand their agreement with the U.S. government by providing an additional 500 million doses of their COVID-19 vaccine at a not-for-profit price for donation to low- and lower-middle-income countries and the organizations that support them. This expanded agreement brings the total number of doses to be supplied to the U.S. government for donation to these countries to one billion.

Pfizer shares were edging up 0.14% to $43.98 in premarket trading. and BioNTech shares were up 0.78% to $344.

Corvus Provides Updates On Oncology and Infectious Disease Programs

Providing an update on its pipeline programs, Corvus said results from a 40-patient COVID-19 study showed primary and secondary endpoints trend toward more favorable outcome for mupadolimab treated patients vs. placebo.

The company also noted that immune response data was consistent with proposed mechanism.

Additionally, the Phase 1b/2 oncology study is currently enrolling patients with head and neck cancers and lung cancer. The company expects to release data from the studies in November.

The stock was up 4.34% at $8.90 in premarket trading.

Cerevel Announces Departure of CFO

Cerevel announced that Kathy Yi has resigned her position as chief financial officer to pursue other personal and professional interests.
Mark Bodenrader, current VP, finance and chief accounting officer, will serve as interim chief financial officer, effective immediately, while the company undertakes a search for a permanent successor.

Yi will remain with the company until November 15, 2021 to ensure a smooth transition.

Abeona's CEO Transitions To Role of Chairman, Names New CEO

Abeona Therapeutics Inc. ABEO announced that Steven Rouhandeh will retire from his position as chairman of the board and as board member, effective Oct. 14. The board has appointed Michael Amoroso as chairman of the board, effective Oct. 15.

Vishwas Seshadri, has been appointed President and CEO and member of the board, effective Oct. 15, replacing Amoroso. Until then, Seshadri will remain in his current role as Head of Research & Clinical Development and will lead the company's search for a new R&D leader with late-stage clinical and regulatory experience in preparation for two pivotal data readouts beginning in 2022.

The stock was down 5.79% at $1.14 in premarket trading.

Biodelivery Sciences Guides Sept. Quarter Revenues Below Consensus

BioDelivery Sciences International, Inc. BDSI expects its September quarter revenues to be in the range of $38 million to $42 million amid its ongoing legal tussle with Alvogen. The consensus estimate calls for revenues of $44.07 million.

The stock was down 3.75% at $3.85 in premarket trading.

Protagonist Gains On Institutional Stake and Insider Buying

Protagonist Therapeutics, Inc. PTGX revealed in a SEC filing that Point72 Asset Management has a 9.1% stake in the company. In a separate filing, the company disclosed that its CEO Dinesh Patel bought 40,000 shares in the company at $4.21 apiece.

The stock was seen up 4.57% at $16.01 in premarket trading.

Inventiva Says Fast Track Designation Given to Lanifibranor Expanded to NASH Patients With Compensated Cirrhosis

Inventiva S.A. IVA said the FDA has decided that the fast track designation previously granted to lanifibranor in NASH encompasses the treatment of NASH patients with compensated cirrhosis.

Arcturus Says Vietnamese Health Regulator Gives Nod For Commencing Phase 2/3 Next-gen mRNA Vaccine Study

Arcturus Therapeutics Holdings Inc. ARCT announced that it has completed dosing of 100 subjects for the Phase 1 portion of the ARCT-154 Phase 1/2/3 clinical trial, which consisted of a two-dose regimen with injections 28 days apart.

The Vietnam Ministry of Health has reviewed the safety data following both injections in the Phase 1 part of the study and has given permission to proceed with enrollment of Phase 2 and Phase 3a. Recruitment of these cohorts is now progressing. Emergency use authorization filing in Vietnam could be as soon as December 2021, the company said.

The stock was adding 2.30% to $53 in premarket trading.

Offerings

Leap Therapeutics, Inc. LPTX announced that it has commenced an underwritten public offering of its common stock and pre-funded warrants to purchase shares of its common stock. All shares of common stock and pre-funded warrants to be sold in the offering will be offered by Leap.

The stock was slipping 11.73% to $3.01 in premarket trading.

On The Radar

PDUFA Dates

The FDA is scheduled to rule on Incyte Corporation's INCY supplemental new drug application for ruxolitinib in steroid-refractory chronic graft-versus-host disease.

Clinical Readouts/Presentations

Onconova Therapeutics, Inc. ONTX will present at the RAS-targeted Drug Development Summit Presentation preliminary data from the Phase 1/2 study of rigosertib plus Opdivo in advanced KRAS-mutated NSCLC.

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