The Daily Biotech Pulse: FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine For Adolescents, Lilly Strikes R&D Collaboration, Vaccine Stocks Novavax, Inovio Sink On Earnings

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 May 10)

• AbbVie Inc. ABBV - Its Allergan subsidiary announced a deal to buy Soliton, Inc. SOLY 
• Alexion Pharmaceuticals, Inc. ALXN
• Novo Nordisk A/S NVO
• Quest Diagnostics Incorporated DGX

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows May 10)

• 4D Molecular Therapeutics, Inc. FDMT
• 4D pharma plc LBPS
• Accelerate Diagnostics, Inc. AXDX
• Acutus Medical, Inc. AFIB
• Adagene Inc. ADAG
• Adaptive Biotechnologies Corporation ADPT
• Agile Therapeutics, Inc. AGRX
• Akoya Biosciences, Inc. AKYA
• Aquestive Therapeutics, Inc. AQST
• Arcturus Therapeutics Holdings Inc. ARCT
• Atea Pharmaceuticals, Inc. AVIR
• Athersys, Inc. ATHX
• Aurinia Pharmaceuticals Inc. AUPH (reacted to publication of positive results for a late-stage asset in lupus nephritis)
• Autolus Therapeutics plc AUTL
• AVROBIO, Inc. AVRO
• Axcella Health Inc. AXLA
• Aytu Biopharma, Inc. AYTU
• BioXcel Therapeutics, Inc. BTAI
• Biomerica, Inc. BMRA (announced first-quarter results)
• Calithera Biosciences, Inc. CALA
• Cara Therapeutics, Inc. CARA
• CASI Pharmaceuticals, Inc. CASI
• Centogene N.V. CNTG (announced an extension to its Parkinson's disease study)
• Co-Diagnostics, Inc. CODX
• Concert Pharmaceuticals, Inc. CNCE
• Connect Biopharma Holdings Limited CNTB
• Decibel Therapeutics, Inc. DBTX
• Deciphera Pharmaceuticals, Inc. DCPH
• Dyadic International, Inc. DYAI
• Enveric Biosciences, Inc. ENVB
• Evofem Biosciences, Inc. EVFM
• Finch Therapeutics Group, Inc. FNCH
• Flexion Therapeutics, Inc. FLXN
• Gain Therapeutics, Inc. GANX
• Galapagos NV GLPG
• Galecto, Inc. GLTO
• Galera Therapeutics, Inc. GRTX
• Geron Corporation GERN
• GlycoMimetics, Inc. GLYC
• Hoth Therapeutics, Inc. HOTH
• Inozyme Pharma, Inc. INZY
• Intercept Pharmaceuticals, Inc. ICPT
• Ionis Pharmaceuticals, Inc. IONS
• Kiniksa Pharmaceuticals, Ltd. KNSA
• Kiromic BioPharma, Inc. KRBP
• LogicBio Therapeutics, Inc. LOGC (announced first-quarter results)
• Lucira Health, Inc. LHDX
• NeuBase Therapeutics, Inc. NBSE
• NeuroBo Pharmaceuticals, Inc. NRBO
• NeuroPace, Inc. NPCE
• NuCana plc NCNA
• OptiNose, Inc. OPTN
• Otonomy, Inc. OTIC
• PainReform Ltd. PRFX
• Protara Therapeutics, Inc. TARA
• Pulmatrix, Inc. PULM
• Reata Pharmaceuticals, Inc. RETA
• Recursion Pharmaceuticals, Inc. RXRX
• RedHill Biopharma Ltd. RDHL
• Relay Therapeutics, Inc. RLAY
• Scopus BioPharma Inc. SCPS
• Sensei Biotherapeutics, Inc. SNSE
• Soligenix, Inc. SNGX (said it will not pursue rolling submission for SGX301 and instead will look to file an NDA in H12022)
• Sonnet BioTherapeutics Holdings, Inc. SONN
• Syros Pharmaceuticals, Inc. SYRS
• Talaris Therapeutics, Inc. TALS
• Talis Biomedical Corporation TLIS
• Universe Pharmaceuticals INC UPC
• Vaxcyte, Inc. PCVX
• Vor Biopharma Inc. VOR
• Voyager Therapeutics, Inc. VYGR (announced first-quarter results)
• VYNE Therapeutics Inc. VYNE
• Windtree Therapeutics, Inc. WINT

Stocks In Focus

Pfizer-BioNTech COVID-19 Vaccine Authorization Expands to Adolescents

BioNTech SE BNTX and Pfizer Inc. PFE announced the Food and Drug Administration has expanded the emergency use authorization for the companies' COVID-19 vaccine to include individuals 12 to 15 years of age. This is the first COVID-19 vaccine authorized in the U.S. for use in this age group.

In after-hours trading, BioNTech shares added 9.68% to $201.49 and Pfizer shares were up 0.33% to $39.99.

Ascendis Reports Positive Results For Phase 2, Open-Label Extension Study of TransCon PTH In Hypoparathyroidism

Ascendis Pharma A/S ASND announced preliminary 58-week results from a continuing open-label extension portion of a Phase 2 trial evaluating the safety, tolerability and efficacy of TransCon PTH in adult subjects with hypoparathyroidism, showing after one year of treatment, the investigational product candidate was well-tolerated at all doses and provided durable benefit in adults with HP.

Data from these subjects provided evidence suggesting they are establishing physiologic calcium metabolism based upon normalization of 24-hour urine calcium excretion and a downward trend toward mid-normal levels in bone markers without the use of therapeutic calcium and vitamin D supplementation.

Kodiak Shares Extend Losses On Potential Delay In Regulatory Filing For KSI-301

Kodiak Sciences Inc. KOD shares extended a post-earnings slide seen Monday, with traders reacting to a potential regulatory filing delay. 

The company is evaluating KSI-301 for four retinal disorder indications. With the company adding another pivotal study, the initial biologic license application filing will be delayed from the earlier communicated timeline of 2022 to the first quarter of 2023.

The stock slipped 14.39% to $87 in after-hours trading.

Cerecor Gets Fast Track Designation For COVID-19 Treatment Candidate

Cerecor Inc. CERC said the FDA has granted fast track designation to CERC-002 for treatment of hospitalized patients with COVID-19.

The stock was up 13.39% to $2.88 in premarket trading Tuesday.

Related Link: The Week Ahead In Biotech (May 9-15): Heron, Apellis FDA Decisions, Presentations and Earnings

Lilly Inks R&D Collaboration With MiNA For Up To $1.25B

Eli Lilly and Company LLY and MiNA Therapeutics Limited announced a global research collaboration to develop novel drug candidates using MiNA's proprietary small activating RNA technology platform.

Under the terms of the agreement, MiNA will utilize its saRNA platform to research up to five targets selected by Lilly that aim to address diseases across Lilly's key therapeutic focus areas, and Lilly will be responsible for preclinical and clinical development and commercialization.

Lilly will pay MiNA a $25-million upfront payment and potential development and commercialization milestones up to a total of $245 million per target, as well as tiered royalties from the low single to low double digits on product sales resulting from the collaboration.

Prothena Earns $60M Milestone Payment For Parkinson's Disease Study Collaboration With Roche

Prothena Corporation plc PRTA announced that it has earned a $60-million milestone payment from its worldwide collaboration with Roche Holding AG RHHBY, based on the first patient dosed in the Phase 2b PADOVA study of prasinezumab in patients with early Parkinson's disease.

In after-hours trading, the stock was up 6.88% to $25.

Chemocentryx, AlloVir Move On Insider Transactions

ChemoCentryx, Inc. CCXI shares, which suffered a bloodbath last week on an adverse Adcom ruling, are finding some support after a filing revealed that Tausif Butt, its COO, bought 10,870 shares at $11.0617 per share.

The stock gained 8.13% to $11.31 in after-hours trading.

AlloVir, Inc. ALVR shares came under pressure after a filing revealed its chief scientific officer Ann Leen sold 150,000 shares in the company at $22.75 per share.

InspireMD To Transfer Listing To Nasdaq

InspireMD, Inc. NPSR said its shares have been approved for listing on the Nasdaq. Trading is expected to begin on May 21 under the symbol "NSPR" on the Nasdaq.

The stock was down 6.12% to $4.45 in premarket trading Tuesday.

Earnings

Geron said its first-quarter net loss per share widened from 8 cents in 2020 to 9 cents in 2021. The company reaffirmed its operating expense burn guidance for 2021.

The stock was up 9.6% to $1.37 in after-hours trading.

Inovio Pharmaceuticals, Inc. INO reported a sharp decline in first-quarter revenues from $1.3 million to $371,000. The loss per share of 27 cents was wider than the 18-cent per share loss estimated by analysts.

The stock was losing 7.05% to $6.20 in premarket trading Tuesday.

Novavax, Inc.'s NVAX first-quarter revenues increased from $3.38 million in 2020 to $447.3 million in 2021. The loss per share widened from 58 cents to $3.05. The company said it intends to file for emergency use authorization for its COVID-19 vaccine candidate with regulators in the U.S., Europe and U.K. in the third quarter.

In after-hours trading, the stock fell 12.77% to $1.40.

On The Radar

Clinical Readouts

Larimar Therapeutics, Inc. LRMR is scheduled to release topline data from placebo-controlled, Phase 1 program evaluating CTI-1601 in Friedreich's ataxia patients.

American Society Of Gene And Cell Therapy Meeting Presentations

AVROBIO, Inc. AVRO: Updated results from a Phase 1/2 clinical trial evaluating hematopoietic stem cell lentiviral gene therapy AVR-RD-04 for cystinosis

Rocket Pharmaceuticals, Inc. RCKT: Interim results from a Phase 1/2 Study of lentiviral-mediated ex-vivo gene therapy for pediatric patients with severe leukocyte adhesion deficiency-I

Flexion Therapeutics, Inc. FLXN: Preliminary data from a Phase 1 single ascending dose trial of FX201, an intra-articular gene therapy candidate, for osteoarthritis

Ultragenyx Pharmaceutical Inc. RARE: Updated results from a Phase 1/2 study of AAV8 gene therapy as a potential treatment in adults with late-onset ornithine transcarbamylase deficiency

Earnings

• InspireMD, Inc. NSPR (before the market open)
• Myovant Sciences Ltd. MYOV (before the market open)
• Taysha Gene Therapies, Inc. TSHA (before the market open)
• Xtant Medical Holdings, Inc. XTNT (before the market open)
• Vascular Biogenics Ltd. VBLT (before the market open)
• Royalty Pharma plc RPRX (before the market open)
• Kindred Biosciences, Inc. KIN (after the close)
• Navidea Biopharmaceuticals, Inc. NAVB (after the close)
• ClearPoint Neuro, Inc. CLPT (after the close)
• Prothena Corporation plc PRTA (after the close)
• Cumberland Pharmaceuticals Inc. CPIX (after the close)
• EDAP TMS S.A. EDAP (after the close)
• Exagen Inc. XGN (after the close)
• Syndax Pharmaceuticals, Inc. SNDX (after the close)
• Otonomy, Inc. OTIC (after the close)
• Ra Medical Systems, Inc. RMED (after the close)
• Opiant Pharmaceuticals, Inc. OPNT (after the close)
• Inari Medical, Inc. NARI (after the close)
• Lyra Therapeutics, Inc. LYRA (after the close)

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