The Daily Biotech Pulse: Restricted Authorization For Pfizer's COVID-19 Booster Dose, AbCellera Strikes Antibody Licensing Deal, Solid Biosciences Issues DMD Data

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. 22)

• Acceleron Pharma Inc. XLRN
• DexCom, Inc. DXCM
• Inspire Medical Systems, Inc. INSP
• Leap Therapeutics, Inc. LPTX (reacted to a common stock offering)
• PDS Biotechnology Corporation PDSB
• Repligen Corporation RGEN

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Sept. 22)

• Ambrx Biopharma Inc. AMAM
• Absci Corporation ABSI
• Acutus Medical, Inc. AFIB
• Alzamend Neuro, Inc. ALZN
• Cardiovascular Systems, Inc. CSII (preannounced revenue shortfall)
• Centessa Pharmaceuticals Limited CNTA
• Cullinan Oncology, Inc. CGEM
• FibroGen, Inc. FGEN (reacted to negative analyst action)
• Frequency Therapeutics, Inc. FREQ (announced new data from its open-label study of FX-322-111 in hearing loss)
• Graphite Bio, Inc. GRPH
• Harpoon Therapeutics, Inc. HARP
• Incyte Corporation INCY (apparently a ‘buy the rumor, sell the news' move as the biopharma announced second FDA approval in two days)
• InMed Pharmaceuticals Inc. INM
• NextCure, Inc. NXTC
• Palisade Bio, Inc. PALI
• Pasithea Therapeutics Corp. KTTA (IPOed Sept. 15)
• Pliant Therapeutics, Inc. PLRX
• Poseida Therapeutics, Inc. PSTX
• Rapid Micro Biosystems, Inc. RPID
• Silverback Therapeutics, Inc. SBTX
• Spruce Biosciences, Inc. SPRB
• TCR2 Therapeutics Inc. TCRR
• Teligent, Inc. TLGT
• Titan Pharmaceuticals, Inc. TTNP
• Vertex Pharmaceuticals Incorporated VRTX
• XBiotech Inc. XBIT

Stocks In Focus

Pfizer-BioNTech Booster COVID-19 Shot Authorized For Use In Older And High-Risk Populations

Pfizer PFE and BioNTech SE BNTX said the Food and Drug Administration amended the emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine to allow for use of a single booster dose, to be administered at least six months after completion of the primary series in select populations.

The booster dose has been approved for use in individuals 65 years of age and older, individuals 18 through 64 years of age at high risk of severe COVID-19 and individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.

The decision comes within a week of an Adcom committee recommending against the use of the booster dose for the broader population and voting in favor of usage in a narrowed group.

Pfizer shares were up 0.91% at $44.35 in premarket trading and BioNTech was seen trading down 0.5 higher to $341. 

Ascendis Announces Positive Phase 2 Data For TransCon PTH In Hyperthroidism

Ascendis Pharma A/S ASND announced 58-week BMD data from central lab reading in the PaTH Forward Trial, a global Phase 2 trial of its investigational product candidate TransCon PTH in adult subjects with hypoparathyroidism, showing stabilization of BMD, in alignment with previously reported observed bone turnover markers. 

Beam Reports Positive Preclinical Data For Lipid Nanoparticle In Liver Editing Studies

Beam Therapeutics Inc. BEAM announced new preclinical data highlighting advancements with the company's approach to developing novel lipid nanoparticle formulations for in vivo liver editing.

In addition, the company reported initial in vivo data demonstrating its delivery capabilities to tissues outside of the liver.

The data will be presented Thursday at the TIDES USA Oligonucleotide & Peptide Therapeutics Conference.

The stock was rising 3.15% to $98.48 in premarket trading.

Related Link: The Week Ahead In Biotech (Sept. 19-25): Incyte, Verrica FDA Decisions And Conference Presentations In The Spotlight

AbCellera Announces Collaboration, Licensing Agreement With Everest For Developing Antibody Therapies

AbCellera Biologics Inc. ABCL and Hong Kong-listed Everest Limited said they have entered into a multiyear collaboration and license agreement to discover therapeutic antibodies for up to 10 targets selected by Everest.

The partnership will help to expand Everest's portfolio of novel medicines across multiple indications, with the initial programs focusing on targets in oncology.

Under the terms of the agreement, Everest will have the rights to develop and commercialize antibodies resulting from the collaboration. AbCellera will receive research payments and is eligible to receive from Everest downstream clinical and commercial milestone payments and royalties on net sales of products.

AbCellera shares were up 1.08% at $21.57 in premarket trading.

Immunocore Announces Publication Of Positive Phase 3 Data For Tebentafusp In Eye Cancer

Immunocore Holdings Plc IMCR announced that data from a Phase 3 trial comparing tebentafusp (IMCgp100) with investigator's choice in first-line metastatic uveal melanoma has been published in the New England Journal of Medicine.

The paper concluded that tebentafusp is the first systemic treatment to show a survival benefit in mUM and should become a new treatment option for this poor prognosis disease.

Offerings

Synlogic SYBX priced its underwritten public offering of 15 million shares of its common stock at a public offering price of $3 per share. The gross proceeds to Synlogic from the offering are expected to be $45 million. All shares of common stock to be sold in the offering are being sold by Synlogic.

The stock was down 9.74% at $3.15 in premarket trading.

Click here to access Benzinga's FDA Calendar. 

On The Radar

Clinical Readouts/Presentations

Solid Biosciences Inc. SLDB will present at the World Muscle Society Congress with long-term data from patients ages 4-6 in the ongoing IGNITE DMD Phase 1/2 clinical trial of SGT-001 in patients with Duchenne muscular dystrophy.

Ahead of the presentation, the company said in a press release the 1.5-year functional data and patient-reported outcome measures for patients ages 4-6 years in the ongoing IGNITE DMD Phase 1/2 clinical trial of SGT-001 demonstrated durable expression and function of microdystrophin protein in biopsy samples collected 12 to 24 months post-dosing of SGT-001.

"Additionally, these data provide encouraging evidence of functional benefit at 1.5 years post-treatment compared with natural history data and show meaningful improvement in patient-reported outcomes," the company said.

The stock was up 2% to $3.06 in premarket trading.

PTC Therapeutics, Inc. PTCT is scheduled to host a conference call for discussing positive results from the PTC518 Phase 1 healthy volunteer study. The company is evaluating PTC518 as a treatment option for Huntington's disease.

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