The Daily Biotech Pulse: FDA Approves Novartis Lung Cancer Drug, 2-Way Contest Emerging For Tetraphase Pharma, Dexcom To Join S&P 500

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 6.)

Adverum Biotechnologies Inc ADVM
Alnylam Pharmaceuticals, Inc. ALNY (reacted to its first-quarter results and clinical pipeline update)
AstraZeneca plc AZN (announced FDA approval for label expansion for its Farxiga)
Bio-Rad Laboratories, Inc. Class A Common Stock BIO
BIO-TECHNE Corp TECH
Catalent Inc CTLT
Cytosorbents Corp CTSO (reacted to its strong first-quarter results)
DexCom, Inc. DXCM
GENMAB A/S/S ADR GMAB (announced first-quarter results)
Horizon Therapeutics PLC HZNP (reacted to first-quarter results)
Imara Inc IMRA
Immunomedics, Inc. IMMU
Immunovant Inc IMVT
Kala Pharmaceuticals Inc KALA
MacroGenics Inc MGNX (reacted to its first-quarter results and sell-side reactions to the results)
Masimo Corporation MASI
Meridian Bioscience, Inc. VIVO (announced partnership with QuantuMDx on its SARS-CoV-2 assay for laboratory use)
ORIC Pharmaceuticals Inc ORIC
OraSure Technologies, Inc. OSUR
Quidel Corporation QDEL
Repligen Corporation RGEN (reacted to its first-quarter results)
TG Therapeutics Inc common stock TGTX (announced raising of $60 million in an at-the-market offering)
Twist Bioscience Corp TWST (announced identification of antibodies against SARS-CoV-2 that could help develop diagnostic tests/therapies)
Vascular Biogenics Ltd VBLT

Down In The Dumps

(Biotech stocks hitting 52-week lows May 6.)

Apyx Medical Corp APYX
Biofrontera AG BFRA
Lyra Therapeutics Inc LYRA (went public May 1)
Sonnet Biotherapeutics Holdings Inc SONN

Stocks In Focus

Novartis Secures FDA Nod For Lung Cancer Drug In Patients With Certain Mutations

Novartis AG NVS announced FDA approval for Tabrecta, an oral MET inhibitor for adult patients with metastatic non-small cell lung cancer whose tumors have a mutation that leads to MET exon 14 skipping as detected by an FDA-approved test.

The company said continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

The FDA also approved FoundationOne CDx as the companion diagnostic for Tabrecta, to aid in detecting mutations that lead to MET exon 14 skipping in tumor tissue, Novartis said.

Novartis licensed the drug from Incyte Corporation INCY under a 2008 agreement.

Novartis shares were down 0.28% at $85.11 in the premarket session Thursday.

La Jolla Jumps Into The Fray To Buy Tetraphase Pharma

La Jolla Pharmaceutical Company LJPC said in a SEC filing that it submitted a non-binding offer to acquire 100% of the equity of Tetraphase Pharmaceuticals Inc TTPH in an all-cash transaction. La Jolla offered $22 million in cash, plus an additional $12.5 million potentially payable under contingent value rights to be issued in the transaction.

Tetraphase meanwhile has signed a definitive agreement to be bought by AcelRx Pharmaceuticals Inc ACRX in a stock-for-stock deal at an exchange ratio of 0.6303 shares of AcelRx for each share of Tetraphase, or approximately $14.4 million as of the close of trading on March 13, 2020, plus a CVR.

In premarket trading, Tetraphase was rallying 49.82% to $2.03, La Jolla was slipping 1.91% to $7.69, while AcelRx was advancing 8.97% to $1.58.

PTC To Buy Censa Pharma

PTC Therapeutics, Inc. PTCT announced an agreement to acquire Censa Pharmaceuticals, Inc., a biopharmaceutical company focused on the development of CNSA-001, for an upfront cash payment of $10 million and up to 850,000 shares of PTC common stock.

PTC is also liable to pay potential future considerations, including $217.5 million in development and regulatory milestones, $109 million in development and regulatory milestones for each additional indication of CNSA-001, net sales milestones up to an aggregate amount of $160 million and a contingent value payment of a percentage of annual net sales ranging from single to low double digits.

CNSA-001 is a clinical-stage investigational therapy for orphan metabolic diseases, including phenylketonuria and other diseases associated with defects in the tetrahydrobiopterin biochemical pathways diagnosed at birth.

The transaction was approved by the boards of both companies, according to PTC. The companies expect the deal to close in the second quarter.

BioNTech Closes Neon Therapeutics Acquisition

BioNTech SE – ADR BNTX, which is partnering with Pfizer Inc. PFE on a coronavirus vaccine program, announced the closing of its previously announced acquisition of Neon Therapeutics through an all-stock transaction.

The new subsidiary based in Cambridge, Massachusetts, will operate under the name of BioNTech US Inc. and serve as BioNTech's U.S. headquarters.

In premarket trading Thursday, BioNTech shares were adding 2.55% to $49.

Dexcom To Replace Allergan In The S&P 500 Index

Dexcom is to join the S&P 500 Index prior to the market open May 12, replacing Allergan plc AGN, which is to be acquired by AbbVie Inc ABBV, S&P said in a release.

Dexcom was seen adding 4.79% to $384.09 in premarket trading Thursday.

Erytech Says Clinical Program On Track

Offering a clinical pipeline update, Erytech Pharma SA ERYP said more than 75% of patients have been enrolled in the TRYbeCA-1 Phase 3 trial that is evaluating its eryapase in second-line metastatic pancreatic cancer.

The company expects to report the results of the interim superiority analysis around the end of 2020 and the final result in the second half of 2021. The investigational asset has been given Fast Track designation by the FDA for the indication.

Following a safety review by an, independent data monitoring committee, Erytech said it has been given the go-ahead to proceed. As of March 31, the company had cash and cash equivalents totaling about $64.6 million.

The stock was rallying 8.24% to $10.51 in premarket trading.

Offerings

GenMark Diagnostics, Inc GNMK priced its previously announced underwritten public offering of 7.25 million shares at $9.65 per share, to generate gross proceeds of about $70 million. The offering is expected to close on or about May 11.

In premarket trading Thursday, the stock was edging up 0.41% to $9.75.

Chembio Diagnostics Inc CEMI announced a proposed public offering of an undetermined number of shares of its common stock. All shares are to be offered by Chembio.

The stock was falling by 0.48% to $12.55 in premarket trading.

Earnings

ADMA Biologics Inc's ADMA first-quarter revenues nearly doubled to $10.2 million and the net loss per share narrowed from 28 cents to 26 cents. The results trailed expectations.

The company had had cash and cash equivalents of $101.2 million as of March 31.

The stock declined was down 8.44% at $2.93 in the premarket session.

Opko Health Inc. OPK reported a decline in its first-quarter revenues from $225.9 million in 2019 to $211.5 million in 2020. The net loss narrowed from 14 cents per share to 9 cents per share. The revenues missed expectations, while the loss per share was in line.

The stock was down 4.27% at $2.24 in the premarket session.