The Daily Biotech Pulse: Key Vaccine Adcom Review For Pfizer-BioNTech, Puma, Immutep, G1 Rally On Breast Cancer Conference Presentations

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 Dec. 9)

• AbbVie Inc ABBV (announced positive results of a late-stage study of upadacitinib in ulcerative colitis)
• Acceleron Pharma Inc XLRN
• Aerpio Pharmaceuticals Inc ARPO
• Apellis Pharmaceuticals Inc APLS
• Avanos Medical Inc AVNS
• Bioanalytical Systems, Inc. BASI
• BioCryst Pharmaceuticals, Inc. BCRX
• BridgeBio Pharma Inc BBIO
• CareDx Inc CDNA
• Castle Biosciences Inc CSTL
• Checkmate Pharmaceuticals Inc CMPI
• CureVac BV CVAC(reacted to a COVID-19 manufacturing deal)
• Curis, Inc. CRIS
• Denali Therapeutics Inc DNLI
• Editas Medicine Inc EDIT
• Eidos Therapeutics Inc EIDX
• Evelo Biosciences Inc EVLO (announced positive readout from atopic dermatitis study)
• Forma Therapeutics Holdings Inc FMTX
• Frequency Therapeutics Inc FREQ
• Guardant Health Inc GH
• Halozyme Therapeutics, Inc. HALO
• Harvard Bioscience, Inc. HBIO
• IGM Biosciences Inc IGMS
• Infinity Pharmaceuticals Inc. INFI
• Intellia Therapeutics Inc NTLA
• Kura Oncology Inc KURA
• Kymera Therapeutics Inc KYMR
• Merrimack Pharmaceuticals Inc MACK
• Myovant Sciences Ltd MYOV
• Natera Inc NTRA
• Neuronetics Inc STIM
• NGM Biopharmaceuticals Inc NGM
• Nkarta Inc NKTX
• Novocure Ltd NVCR
• Omnicell, Inc. OMCL (moved on reports of a takeover approach by Baxter International Inc BAX)
• Oncternal Therapeutics Inc ONCT
• Otonomy Inc OTIC
• Pacific Biosciences of California Inc PACB
• Pfizer Inc. PFE (reacted to briefing document release)
• Rocket Pharmaceuticals Inc . RCKT (reacted to an early-stage readout for gene therapy candidate)
• Seer Ord Shs Class A (Proposed) SEER (IPOed Friday)
• Sellas Life Sciences Group Inc SLS
• Sesen Bio Inc SESN
• Silverback Therapeutics Inc SBTX
• Spero Therapeutics Inc SPRO
• Tarsus Pharmaceuticals Inc TARS
• Travere Therapeutics Inc TVTX
• Ultragenyx Pharmaceutical Inc RARE
• Zentalis Pharmaceuticals Inc ZNTL
• Xenetic Biosciences Inc XBIO ( announced positive results from Russian partner's Phase 3 study that uses Xenetic's platform technology)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Dec. 9)

• Bellicum Pharmaceuticals Inc BLCM
• Homology Medicines Inc FIXX
• Maravai Lifesciences Holdings Inc MRVI
• Nabriva Therapeutics PLC – ADR NBRV

Stocks In Focus

San Antonio Breast Cancer Symposium Presentations

G1 Therapeutics Inc GTHX said final data from its randomized Phase 2 trial of trilaciclib in metastatic triple-negative breast cancer showed that trilaciclib significantly improved overall survival for patients treated with trilaciclib in combination with a chemotherapy regimen of gemcitabine/carboplatin compared with the chemo combo alone.

The company said it plans to begin the registrational trial in 2021.

The stock was up 9.10% to $20.50 in after-hours trading.

Puma Biotechnology Inc PBYI announced updated results from the ongoing Phase 2 SUMMIT trial of neratinib, showing the breast cohort that received neratinib in combination with trastuzumab and fulvestrant showed, for the 37 RECIST efficacy evaluable patients, 17 patients experienced a confirmed objective response, including one complete response and 16 partial responses, and 20 patients experienced clinical benefit. The median duration of response was 10.9 months and the median progression-free survival was 8.3 months, the company said.

In after-hours session, the stock gained 8.81% to $11.49.

Australian biopharma Immutep ADS Representing 10 Ord Shs IMMP said its Chinese partner, EOC Pharma will commence a new Phase 2 clinical trial of Immutep's eftilagimod alpha in up to 152 metastatic breast cancer patients in China.

The study will evaluate the investigational asset in combination with chemotherapy compared to placebo, plus chemotherapy. The study is set to begin in the first quarter of calendar year 2021.

Immutep said the study follows encouraging data reported by it in its APIAC Phase 2b study announced at the end of March and presented at the SABCS.

The presentation at the SABCS showed statistically significant overall survival benefit in the total population, with median survival benefit of 2.7 more months in the control arm over the placebo arm.

The stock jumped 62.04% to $3.50 in after-hours trading.

Editas Medicine Submits IND Application For Initiating Phase 1/2 Study of Gene Therapy In Sickle Cell Disease

Editas Medicine Inc EDIT said it submitted an investigational new drug application with the FDA for the initiation of a Phase 1/2 clinical trial of EDIT-301, an experimental CRISPR/Cas12a gene editing medicine in development for the treatment of sickle cell disease. The Company previously received rare pediatric disease designation from the FDA for EDIT-301.

"This IND submission is a key milestone for Editas as we continue to advance several ex vivo cell therapy medicines. This submission brings us one step closer to entering the clinic with our potentially best-in-class, transformative, and durable medicine for people living with sickle cell disease," said Cynthia Collins, CEO of, Editas Medicine.

The stock rose 6.70% to $53.97 in after-hours trading.

ObSeva Reports Positive Late-stage Readout For Linzagolix In Treating Uterine Fibroid

Obseva SA OBSV announced additional data from the Phase 3 PRIMROSE 1 and 2 study that confirmed efficacy and safety of linzagolix in the treatment of uterine fibroids. The PRIMROSE 1, 52-week results showed that unique low-dose option, ie 100 mg, without add-back therapy, or ABT, has the potential to address the needs of up to 50% of U.S. women with uterine fibroids for whom ABT may be contraindicated. The results confirmed the sustained efficacy and safety, with a potential best-in-class high-dose option of 200mg, with ABT.

The PRIMROSE 2, 76-week results showed continued pain reduction and demonstrated evidence of bone mineral density recovery following 52 weeks of treatment.

Biogen Files Regulatory Application For Aducanumab In Japan

Biogen Inc BIIB and Eisai Co., Ltd ESALY said the former has submitted a Japanese NDA to the Ministry of Health, Labor and Welfare for aducanumab, an investigational therapy for Alzheimer's disease.

Aducanumab has a PDUFA action date of March 7 in the U.S. Despite an Adcom snub, analysts are largely optimistic it will be approved in the U.S.

Ultragenyx Gets Orphan Drug Designation For UX701 in Wilson Disease

Ultragenyx Pharmaceutical Inc RARE said the FDA has granted orphan drug designation to UX701 for the treatment of Wilson disease, a larger rare metabolic disease that affects more than 50,000 people in the developed world.

LabCorp Gets Emergency Use Authorization For First Over-the-counter COVID-19 Home Test

Laboratory Corp. of America Holdings LH said the FDA granted emergency use authorization for the Pixel by LabCorp COVID-19 Test Home Collection Kit to become the first to be available over the counter without requiring a prescription. The approval will enable LabCorp to potentially distribute the kit through retail channels.

Offerings

Xenetic said it has entered into a securities purchase agreement with several institutional and accredited investors for the sale of 2.449 million shares of its common stock at a purchase price of $2.45 per share, in a registered direct offering priced at-the-market under Nasdaq rules.

The stock slipped 9.78% to $2.86 in after-hours trading.

Oncternal announced an increase in the size of the previously announced offering to16.67 million shares, with the offering priced at $4.50 per share, potentially raising $75 million in gross proceeds. The closing of the offering is expected to occur on or about December 14, subject to satisfaction of customary closing conditions.

The stock slumped 15.08% to $5.35 in after-hours trading.

Rocket Pharma priced an upsized underwritten public offering of 4.643 million shares of its common stock at a price of $56 per share for raising gross proceeds of about $260 million.

ALX Oncology Holdings Inc -ALXO priced an upsized underwritten public offering of 2.38 million shares of its common stock at a price of $76 per share. All of the shares of common stock are being offered by the company. The gross proceeds to ALX Oncology are expected to be about $180.9 million.

On The Radar

Adcom Schedule

The Center for Biologics Evaluation and Research's Vaccines and Related Biological Products Advisory Committee, or VRBPAC, will meet in an open session to discuss emergency use authorization of the vaccine candidate developed by Pfizer-BioNTech SE – ADR BNTX for the prevention of COVID-19 in individuals 16 years of age and older.

Protection after a single shot, likely durability of protection, timing of updated stability data, details on the economic arrangement between Pfizer and BioNTech as well as reinfection risk with COVID-19 will likely be discussed at length during the VRBPAC meeting, after which FDA is likely to authorize emergency use for BNT162b2, SVB Leerink analyst Daina Graybosch said in a recent note.