The Daily Biotech Pulse: FDA Nod For Pfizer, Sorrento's COVID-19 Antibody Animal Data, Orphazyme's Wall Street Debut - Pfizer (NYSE:PFE)

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. 28)

10X Genomics Inc TXG
Arena Pharmaceuticals, Inc. ARNA
Beigene Ltd BGNE
Cardiff Oncology Inc CRDF
Celldex Therapeutics, Inc. CLDX
Evogene Ltd EVGN
Fate Therapeutics Inc FATE
Guardant Health Inc GH
InVitae Corp NVTA
Kaleido Biosciences Inc KLDO
Kura Oncology Inc KURA
Lantern Pharma Inc. LTRN
Momenta Pharmaceuticals, Inc. MNTA
Pacific Biosciences of California Inc PACB
Prelude Therapeutics Incorporated PRLD (listed Thursday)
Seattle Genetics, Inc. SGEN
Shockwave Medical Inc (NASDAQ: SWAV
Turning Point Therapeutics Inc TPTX)
Twist Bioscience Corp TWST

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Sept. 28)

Abeona Therapeutics Inc ABEO (announced departure of CEO and board members stepping down)
AnPac Bio-Medical Science Co Ltd – ADR ANPC
Fusion Pharmaceuticals Inc FUSN
Gritstone Oncology Inc GRTS
Happiness Biotech Group Ltd HAPP
Hoth Therapeutics Inc HOTH
Neos Therapeutics Inc NEOS
Odonate Therapeutics Inc ODT
Oncternal Therapeutics Inc ONCT
Orchard Therapeutics PLC – ADR ORTX (announced EMA's Priority Medicines designation for gene therapy candidate OTL-203 in the treatment of mucopolysaccharidosis type I)
PainReform Ltd PRFX
Radius Health Inc RDUS
Silence Therapeutics ADR Representing 3 Ord Shs SLN
Teligent Inc (NEW JERSEY) TLGT
Tricida Inc TCDA

Stocks In Focus

Pfizer's Rheumatoid Arthritis Drug Gets Label Expansion

Pfizer Inc. PFE said the FDA approved two formulations — a tablet and oral solution — of Xeljanz for the treatment of children and adolescents 2 and older with active polyarticular course juvenile idiopathic arthritis.

The company said Xeljanz 5mg tablets are immediately available, while the oral solution is expected to be available by the end of the first quarter of 2021.

The stock was trading 0.3% higher to $36.50 premarket Tuesday.

Sorrento Reports Positive Preclinical COVID-19 Antibody Data

Sorrento Therapeutics Inc SRNE announced preclinical data on COVI-GUARD, codenamed STI-1499, and COVI-AMG, codenamed STI-2020, neutralizing antibodies against SARS-CoV-2 as well as a D614G virus variant infection, showing that both demonstrated potent neutralizing activities against SARS-CoV-2 virus infection in preclinical models.

STI-1499 nAb has been cleared by the FDA for a Phase 1 clinical trial in hospitalized COVID-19 patients. STI-2020 is an affinity-matured version of the COVI-GUARD nAb and has demonstrated a greater than 50-fold increase in potency in in vitro experiments, the company said.

"In preclinical cell-based assay, both STI-1499 and STI-2020 have shown 100% in vitro neutralization of SARS-CoV-2 at concentrations of 6 µg/ml and 78 ng/ml," respectively, according to Sorrento.

The company said it intends to submit an IND for STI-2020 as soon as possible.

In premarket trading Tuesday, Sorrento shares were rallying 5.02% to $10.60.

Ascendis Reports Positive Results In Phase 2 Hormone Study

Ascendis Pharma A/S ASND announced preliminary six-month results from the open-label extension portion of a Phase 2 trial evaluating TransCon PTH in adult subjects with hypoparathyroidism, showing subjects in the trial consistently improved their quality of life, while at the same time demonstrating improvement in 24-hour urine calcium excretion and serum phosphate.

"We have now filed an IND amendment to initiate the U.S. sites of the phase 3 PaTHway Trial evaluating TransCon PTH in adult patients with hypoparathyroidism, which will enable us to eventually provide this therapy to patients as soon as possible," the company said in a press release.

Summit Trades Higher On Disclosure of Institutional Stake

Summit Therapeutics Inc SMMT moved higher after a SEC filing revealed that Mahkam Zanganeth, Mahkam Zanganeh Revocable Trust and Shaun Zanganeh Irrevocable Trust beneficially own about 5.33 million shares, or a 7.8% stake, in the company.

The stock rose 6.63% to $3.70 premarket.

Celyad Strikes Colorectal Cancer Study Partnership With Merck

Celyad ADR Representing Ord Shs CYAD said it has entered into a clinical trial collaboration with Merck & Co., Inc. MRK to conduct the Phase 1b KEYNOTE-B79 clinical trial, which will evaluate Celyad's investigational non-gene edited allogeneic CAR T candidate, CYAD-101 with Keytruda in refractory metastatic colorectal cancer patients with microsatellite stable/mismatch-repair proficient disease.

Adcom Meeting For TransMedics Postponed

TransMedics Group Inc TMDX said the FDA has temporarily postponed the Adcom meeting to review the company's premarket approval application for its OCS Heart to allow time to review additional, already collected, short- and longer-term data from the OCS Heart EXPAND trial and EXPAND Continued Access Protocol.

The regulatory agency has communicated that it will review the additional data expeditiously to allow rescheduling of the FDA meeting to occur in the near future, the company said. The meeting was originally scheduled for Oct. 7.

The stock edged down 0.21% to $14.50 in after-hours trading.

Orgenesis to Acquire Koligo Therapeutics

Cell and gene therapy company Orgenesis Inc ORGS announced an agreement to buy Koligo Therapeutics, Inc., a regenerative medicine company, for $15 million in Orgenesis shares and the assumption of $1.3 million in Koligo debt. The deal is expected to be completed by the end of 2020.

Axsome Snags $225M Loan

Axsome Therapeutics Inc AXSM said it has secured a $225-million term loan facility with Hercules Capital, Inc. HTGC.

The committed capital strengthens its balance sheet through the anticipated commercial launches of its two lead product candidates, AXS-05 for major depressive disorder and AXS-07 for migraine, and extends its cash runway into at least 2024 based on current operating plans, the company said.

In premarket trading Tuesday, the stock was down 3.22% at $74.

Offerings

Beam Therapeutics Inc BEAM announced the commencement of a proposed public offering of 4.5 million shares of its common stock. All of the shares are being offered by the company.

The stock was down 6.62% at $25.10 premarket Tuesday.

PDUFA Date

The FDA is scheduled to give its verdict on Eton Pharmaceuticals Inc's ETON NDA for Alkindi Sprinkle, which is being evaluated as a replacement therapy for pediatric adrenal insufficiency, including congenital adrenal hyperplasia in patients from birth to less than 17 years of age.

Earnings

AngioDynamics, Inc. ANGO (before the market open)

IPOs

Orphazyme A/S, a late-stage biopharma pioneering the heat-shock protein response for the treatment of neurodegenerative orphan diseases, priced its initial public offering of 3.97 billion ADSs at $11 per ADS. Each ADS represent one ordinary share of the company.

Orphazyme also priced a concurrent private placement of 3.65 million ordinary shares in Europe at a price of 70.1844 Danish Krone ($11.04).

The gross proceeds from the global offering are expected to be around $83.78 million.

The ADSs will begin trading on the Nasdaq under the ticker symbol "ORPHA."

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