The Daily Biotech Pulse: MacroGenics Breast Cancer Drug Wins FDA Approval, Adcom Test Awaits Moderna, Virios To Make Wall Street Debut

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. 16)

Aclaris Therapeutics Inc ACRS
Bioanalytical Systems, Inc. BASI
BioLife Solutions Inc BLFS
Castle Biosciences Inc CSTL
Cerevel Therapeutics Holdings Inc CERE
Chimerix Inc CMRX
Codexis, Inc. CDXS
Corcept Therapeutics Incorporated CORT
Eli Lilly And Co LLY
Frequency Therapeutics Inc FREQ
Globus Medical Inc GMED
Idera Pharmaceuticals Inc IDRA
Inhibrx Inc INBX
Medpace Holdings Inc MEDP
Morphic Holding Inc MORF
Nanobiotix ADR Representing Ord Shs NBTX
NeoGenomics, Inc. NEO
Ocular Therapeutix Inc OCUL
Otonomy Inc OTIC
Revolution Medicines Inc RVMD
Sesen Bio Inc SESN
SI-Bone Inc SIBN - announced that health insurer Humana Inc HUM will begin to cover minimally invasive SI joint fusion using triangular titanium implants
Spero Therapeutics Inc SPRO (announced addition to the Nasdaq Biotechnology Index)
Summit Therapeutics Inc SMMT
TG Therapeutics Inc common stock TGTX
Ultragenyx Pharmaceutical Inc RARE
United Therapeutics Corporation UTHR
Xencor Inc XNCR
X T L Biopharmaceuticals Ltd XTLB
Zai Lab Ltd – ADR ZLAB

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Dec. 16)
AbCellera Biologics Inc ABCL (listed on Friday following its IPO)
Galapagos ADR Representing Ord Shs GLPG -partner Gilead Sciences, Inc. GILD said it is not pursuing approval of filgotinib in rheumatoid arthritis in the U.S.
Kinnate Biopharma Inc KNTE
Olema Pharmaceuticals Inc OLMA
Vivos Therapeutics Inc VVOS

Stocks In Focus

MacroGenics Breast Cancer Drug Gets Regulatory Clearance, Commercialization Planned for March

MacroGenics Inc MGNX said the FDA has approved Margenza in combination with chemotherapy for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease.

Margenza is the first product approved from MacroGenics' pipeline, the company said.

The company looks ahead to launch the product in March 2021.

The stock was up 8.09% at $26.27 premarket Thursday.

Mixed Verdict For Evolus In Botox Trade Secret Lawsuit

Evolus Inc EOLS said the U.S. International Trade Commission issued its final determination in the action brought by AbbVie Inc's ABBV Allergan unit and Medytox against Daewoong and Evolus, reaffirming in part the initial determination of the administrative law judge finding a violation of Section 337 of the Tariff Act of 1930 as it relates to certain manufacturing processes.

The ITC, however, reversed the ALJ's finding that a trade secret exists with respect to Medytox's bacterial strain. The commission issued orders preventing the import, sale and marketing of Jeuveau, a Botox rival, in the U.S. for 21 months, reducing it from the 10-year recommendation from the ALJ in July.

Evolus said will now focus on overturning the decision by mobilizing interested parties close to this matter through the presidential review process, which will go on for a 60-day period.

Evolus shares were up 16.89% premarket at $4.29.

Amgen Submits Regulatory Application For Drug To Treat Lung Cancer With KRAS Mutation

Amgen, Inc. AMGN said it has submitted to the FDA an NDA for sotorasib, an investigational KRASG12C inhibitor for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer, as determined by an FDA-approved test, following at least one prior systemic therapy.

"Sotorasib was the first KRASG12C inhibitor to enter the clinic and now is on track to potentially be the first approved targeted therapy for patients with advanced NSCLC harboring the KRAS G12C mutation," the company said.

Separately, the company announced a 10% hike to the quarterly dividend.

The stock added 0.80% to $230.27 in after-hours trading.

Zynerba To Conduct Pivotal Trial As Confirmatory Trial Required For Zygel Approval In Fragile X Syndrome

Following a meeting with the FDA regarding its Zygel in fragile X syndrome, Zynerba Pharmaceuticals Inc ZYNE said it plans to conduct a double-blind, placebo-controlled pivotal trial in patients with FXS who have a highly methylated FMR1 gene to confirm the positive results observed in this population of responders in the CONNECT-FX trial. The company expects to initiate the pivotal trial before the end of 2021.

Zynerba said it believes that positive results from this confirmatory trial would be sufficient to support the submission of an NDA for Zygel in FXS.

Aurinia Out-Licenses Rights To Kidney Inflammation Dug Outside The US To Japan's Otsuka

Aurinia Pharmaceuticals Inc AUPH announced a collaboration and license agreement with Japan's Otsuka Pharmaceutical for the development and commercialization of oral voclosporin for the treatment of lupus nephritis in the European Union, Japan, as well as the U.K., Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein and Ukraine.

The agreement provides for Aurinia receiving an upfront cash payment of $50 million, and potentially up to an additional $50 million in regulatory and reimbursement milestone payments. Additionally, Aurinia will receive tiered royalties ranging from 10%-20% on net sales upon commercialization, along with additional milestone payments based on the attainment of certain annual sales by Otsuka.

Voclosporin is currently being evaluated by the FDA, with a PDUFA action goal date of Jan. 22.

Aurinia shares were slipping 2.77% to $14.75 in premarket trading Thursday.

Selecta Biosciences Rallies On Insider Buying

Selecta Biosciences Inc's SELB chief commercial officer Peter Traber purchased 40,000 shares of the company at $3.2356 on Monday, according to a Form-4 filing by the company with the SEC.

The stock was up 7.19% premarket at $3.13.

Ziopharm Budges To Pressure By Activist Investor WaterMill, Appoints Rival Slate Of Directors; Chairman To Depart

ZIOPHARM Oncology Inc. ZIOP said following the content solicitation by WaterMill Asset Management, Robert Postma Jaime Vieser and Holger Weis have been formally elected to its board.

Chairman Scott Tarriff will depart the Board effective immediately, it added.

On Monday, the company announced resignation of its CFO.

In after-hours trading, the stock was up 5.07% to $2.90.

Surface Oncology Out-Licenses Preclinical Asset To GlaxoSmithKline For Up To $815M

Surface Oncology Inc SURF announced an agreement for GlaxoSmithKline plc GSK to exclusively license worldwide development and commercial rights to its preclinical program SRF813, an inhibitory protein expressed on natural killer cells and T cells, for an $85-million upfront payment.

Surface Oncology may receive up to an additional $730 million in future milestone payments, as well as be eligible to receive tiered royalties on global net sales.

Surface Oncology shares were trading up 3.11% to $10.27, while GlaxoSmithKline was adding 2.39% to $37.76.

Otonomy Reports Positive Phase 1/2 Study Of OTO-413 For Hearing Loss

Otonomy announced positive top-line results from the Phase 1/2 clinical trial of OTO-413 in subjects with speech-in-noise hearing difficulty, with the investigational asset found to be well-tolerated across all dose cohorts.

Furthermore, there was demonstration of therapeutic activity of OTO-413 versus placebo across multiple clinically validated speech-in-noise hearing tests at consecutive time points (days 57 and 85), the company said.

Based on these results, the company said it plans to continue development of OTO-413 for the treatment of hearing loss.

Otonomy shares were rallying 4.13% to $5.80 premarket Thursday.

Offerings

SCYNEXIS Inc SCYX said it has commenced an underwritten public offering of shares of its common stock and warrants to purchase shares of its common stock, including pre-funded warrants to purchase common stock in lieu of common stock for certain purchasers. All of the securities are being sold by the company.

The stock was down 18.14% premarket at $6.

Gamida Cell Ltd GMDA announced the launch of a follow-on public offering of its ordinary shares. All of the shares in the offering are to be sold by Gamida Cell.

On The Radar

Adcom Review

Moderna MRNA will face the FDA's Center for Biologics Evaluation and Research's Vaccines and Related Biological Products Advisory Committee on Dec. 17 regarding the EUA application it has filed for its coronavirus vaccine candidate mRNA-1273.

Moderna's shares have fully discounted near-term COVID-19 vaccine revenue, Morgan Stanley's Matthew Harrison said in a note Wednesday.

Clinical Readouts

BioCardia Inc BCDA said it will provide ahead of the market open an update on the feedback from the data safety monitoring board, which evaluated the interim data from its pivotal Phase 3 CardiAMP Heart Failure Trial that is enrolling nationwide for infusion of BioCardia's CardiAMP autologous cell therapy to the myocardium.

MeiraGTx Holdings PLC MGTX is scheduled to discuss the first cohort of three patients treated in the Phase 1 AQUAx clinical trial that is evaluating its investigational gene therapy AAV-hAQP1 in radiation-induced xerostomia.

Earnings

Applied DNA Sciences Inc APDN (after the close)

IPOs

Virios therapeutics, a biotech focused on advancing novel antiviral therapies to treat diseases associated with a viral triggered abnormal immune response, priced its initial public offering of 3 million shares of its common stock at $10 per share, for gross proceeds of $30 million.

The shares are expected to begin trading on the Nasdaq under the ticker symbol "VIRI." The offering is expected to close on Dec. 21.

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