The Daily Biotech Pulse: Novartis Gets Adcom Backing, Sio Gene Data, 2 IPOs, BioNTech Clinches China Vaccine Supply Deal

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. 15)

• Anchiano Therapeutics Ltd – ADR ANCN (announced a reverse merger with Chemomab)
• Arvinas Inc ARVN
• Beam Therapeutics Inc BEAM
• Bioanalytical Systems, Inc. BASI
• BioCardia Inc BCDA
• BioLineRx ADR Representing 15 Ord Shs BLRX
• BioTelemetry Inc BEAT
• Chimerix Inc CMRX
• Corcept Therapeutics Incorporated CORT
• Frequency Therapeutics Inc FREQ
• Globus Medical Inc GMED
• Inhibrx Inc INBX
• MannKind Corporation MNKD
• Ocular Therapeutix Inc OCUL
• PRA Health Sciences Inc PRAH
• Prevail Therapeutics Inc PRVL (announced a deal to be bought by Eli Lilly And Co LLY)
• Sesen Bio Inc SESN
• Solid Biosciences Inc SLDB
• SpringWorks Therapeutics Inc SWTX
• Summit Therapeutics Inc SMMT
• TG Therapeutics Inc common stock TGTX
• Ultragenyx Pharmaceutical Inc RARE
• Veru Inc VERU
• Xencor Inc XNCR
• XOMA Corp XOMA
• Zai Lab Ltd – ADR ZLAB

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Dec. 15)

• AbCellera Biologics Inc ABCL (listed on Friday following its IPO)
• Aptose Biosciences Inc APTO
• Avita Therapeutics Inc RCEL
• InMed Pharmaceuticals Inc INM
• Olema Pharmaceuticals Inc OLMA
• Opthea Spon American Depositary Receipts Representing 8 Ord Shs OPT
• Vivos Therapeutics Inc VVOS

Stocks In Focus

Adcom Recommends Approval of Novartis Heart Failure Drug For an Expanded Indication

Novartis AG NVS said FDA's Cardiovascular and Renal Drugs Advisory Committee voted 12 to 1 that the data presented support the use of its Entresto (sacubitril/valsartan) in treatment of patients with heart failure with preserved ejection fraction, or HFpEF.

If approved by the FDA, Entresto could become the first therapy indicated for use in treatment of patients with HFpEF, as well as the first medication approved for both major types of chronic heart failure, HFpEF and heart failure with reduced ejection fraction, both based on trials that included active comparators valsartan and enalapril, respectively, the company said.

Aurinia Agrees With Lonza For Dedicated Manufacturing Facility For Investigational Kidney Inflammation Drug

Aurinia Pharmaceuticals Inc AUPH and Swiss CDMO Lonza Ltd. announced they have expanded their exclusive manufacturing relationship to build a dedicated manufacturing capacity for voclosporin within Lonza's existing small molecule API facility in Visp, Switzerland.

The monoplant is estimated to be operational in 2023.

Aurinia's NDA for voclosporin in the treatment of lupus nephritis has been granted priority review by the FDA, with a PDUFA goal date of Jan. 22, 2021.

Aurinia shares were up 2.26% to $15.39 in after-hours trading.

Sio Gene Reports Positive Phase 1/2 Data For Rare, Inherited Autoimmune Disease

Sio Gene Therapies Inc SIOX reported positive six-month follow-up data from the low-dose cohort of the dose escalation study of AXO-AAV-GM1, its AAV9-based gene therapy candidate for the treatment of GM1 gangliosidosis.

Initial data from the ongoing Phase 1/2 study in five patients in the low-dose cohort showed that AXO-AAV-GM1 was generally well tolerated with a favorable safety profile and provide early indications of clinical disease stability, the company said.

The stock jumped 54.23% to $4.38 in after-hours trading.

BioNTech to Supply 100M Doses of Coronavirus Vaccine Candidate to China In 2021

BioNTech SE – ADR BNTX and its Chinese partner Shanghai Fosun Pharma announced an agreement to supply Mainland China with an initial 100 million doses of BNT162 mRNA-based vaccine candidate against COVID-19 in 2021, subject to regulatory approval.

Initial supply will be delivered from BioNTech's production facilities in Germany.

BioNTech and Fosun announced a strategic collaboration in March to jointly develop and commercialize a potential mRNA vaccine. In late November, the companies initiated a Phase 2 study of BNT162b2 in Jiangsu Province in China, recruiting 960 healthy participants, between 18 and 85 years old, to assess the safety and immunogenicity of the vaccine candidate and to support future biologic license application in China.

BioNTech, which is partnering with Pfizer Inc. PFE for the BNT162b2 program, has received regulatory nod for the emergency use of the vaccine candidate in countries such as the U.K., Canada, Bahrain, Saudi Arabia and the U.S.

Sage Appoints Former Alnylam Executive as CEO

SAGE Therapeutics Inc SAGE announced the appointment of Barry Greene, who most recently served as president of Alnylam Pharmaceuticals, Inc.'s ALNY, as its CEO. Sage's CEO since 2013 Jeff Jonas will transition to the role of chief innovation officer.

Gilead, Galapagos Amend Filgotinib Agreement Following Decision Not to Pursue Approval of Rheumatoid Arthritis In U.S.

Gilead Sciences, Inc. GILD and Galapagos ADR Representing Ord Shs GLPG announced that the companies have agreed to amend their existing arrangement for the commercialization and development of filgotinib.

Based on the feedback received from the FDA during the NDA review process and in the Type A meeting, Gilead said it will not pursue FDA approval of filgotinib for rheumatoid arthritis, or RA.

Under the amended agreement, Galapagos will assume sole responsibility in Europe for filgotinib in RA, where 200 mg and 100 mg doses are approved for the treatment of moderate to severe RA, and in all future indications. Galapagos will receive payments from Gilead in connection with changes in responsibility for the commercialization and development of filgotinib in Europe, while Gilead will receive royalties from European sales of filgotinib.

In after-hours trading, Gilead edged down to $59.41, while Galapagos slipped 11.17% to $106.11.

BioLineRx Reports Positive Results from Mid-stage Study of Triple Combo In Pancreatic Cancer

BioLineRx announced positive results from the triple combination arm of the its Phase 2a COMBAT/KEYNOTE-202 clinical study evaluating motixafortide in combination with Merck & Co., Inc.'s MRK Keytruda and chemotherapy in patients with second-line stage IV pancreatic ductal adenocarcinoma.

The results of the study showed substantial improvement as compared to historical results in the primary endpoint of objective response rate as well as key secondary endpoints of confirmed objective response rate, overall survival, progression free survival, and disease control rate.
The combination was generally well tolerated, with a safety profile consistent with the individual safety profile of each component alone, BioLineRx added.

BioLineRx shares were rallying 21.27% to $4.39 in premarket trading Wednesday.

Penumbra Voluntarily Recalls Jet 7 Reperfusion Catheter

Penumbra Inc PEN said it is voluntarily recalling all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology, citing potential susceptibility to distal tip damage during use.

Distal tip damage in conjunction with pressurization or contrast injection may result in potential vessel damage, and subsequent patient injury or death, the company said.

The stock moved down 6.79% to $176 in after-hours trading.

UroGen CEO Buys Shares

Urogen Pharma Ltd URGN shares reacted to insider buying of shares. A Form 4 filing with the SEC revealed that CEO Elizabeth Barrett acquired 10,000 shares in the company at a price of $18.50. Along with the recent purchase, the CEO owned 229,117 shares.

The stock rallied 13.88% to $21 in after-hours trading.

Cellectis Withdraws Public Offering Citing Market Conditions

Cellectis SA CLLS said it has withdrawn the proposed underwritten offering of ADSs due to market conditions.
The company said it believes that it is not in the best interest of its stockholders to raise the equity capital in the current market environment. Cellectis remains well capitalized with a cash position at the end of the third quarter of 2020 of $308 million to fund its key programs into 2022, it added.

Offerings

ENDRA Life Sciences Inc. NDRA said it intends to offer shares of its common stock in an underwritten public offering.

The stock plunged 17.78% to 67 cents in after-hours trading.

Phathom Pharmaceuticals Inc PHAT announced its intention to offer, subject to market and other conditions, 2.25 million shares of its common stock in an underwritten public offering. All of the shares to be sold in the offering are to be sold by the company.

On The Radar

Earnings

Centogene NV CNTG (before the market open)

IPOs

San Diego, California-based BioAtla, Inc., a clinical-stage biopharma developing highly specific and selective antibody-based therapeutics for the treatment of solid tumor cancer, said it priced its upsized initial public offering of 10.5 million shares at $18 per share compared to the previously estimated price range of $15-$17. Gross proceeds from the offering are expected to be $189 million. The shares will begin trading on the Nasdaq under the ticker symbol BCAB.

Scopus biopharma is offering 500,000 shares at an IPO price of $5.50 per share. The shares will begin trading on the Nasdaq under the ticker symbol SCPS.

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