The Daily Biotech Pulse: Bristol-Myers Squibb-Celgene Deal Faces Setback, Syneos Hit By SEC Probe, FDA Cheer For T2 Biosystems

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 on Feb. 27)

• Abbott Laboratories ABT
• argenx SE – ADR ARGX
• AstraZeneca plc AZN
• Biohaven Pharmaceutical Holding Co Ltd BHVN
• CareDx Inc CDNA
• Cerecor Inc CERC
• EXACT Sciences Corporation EXAS(has been seeing upward momentum since a Goldman upgrade Tuesday)
• Ionis Pharmaceuticals Inc IONS (in reaction to Q4 results)
• Inspire Medical Systems Inc INSP (in reaction to Q4 results)
• Eli Lilly And Co LLY
• Masimo Corporation MASI (in reaction to Q4 results)
• Merck & Co., Inc. MRK
• Regeneron Pharmaceuticals Inc REGN
• Tandem Diabetes Care Inc TNDM (in reaction to Q4 results)
• Tcr2 Therapeutics Inc TCRR (IPOed on Feb. 14)

Down In The Dumps

(Biotech stocks hitting 52-week lows on Feb. 27)

• ANCHIANO THERAP/S ADR ANCN
• Inogen Inc INGN(reacted to its mixed Q4)
• Karyopharm Therapeutics Inc KPTI(reacted to negative FDA panel vote )
• Mylan NV MYL (reacted to below-consensus Q4 EPS and FY19 EPS guidance)
• VERONA PHARMA P/S ADR VRNA

Stock In Focus

Key Bristol-Myers Squibb Shareholder Opposes Celgene Deal

Celgene Corporation CELG shares came under pressure in after-hours trading after Wellington Management Co, which owns an 8.3-percent stake in Bristol-Myers Squibb Co BMY, said it does not believe the Celgene deal is an attractive path toward accomplishing the goal of securing differentiated science and broadening Bristol-Myers Squibb's future revenue base.

Celgene shares fell 9.67 percent to $82.19 in after-hours trading.

T2 Biosystems' Diagnostic Panel Gets Breakthrough Designation

T2 Biosystems Inc TTOO said the FDA granted Breakthrough Device designation for its TR2Resistance Panel, a diagnostic panel to detect 13 resistance genes from both gram-positive and gram-negative pathogens from a single patient blood sample, without having to wait for blood culture.

"The Breakthrough Designation allows T2 Biosystems to work closely with the FDA during the premarket review phase to ensure patients can have access to the benefits of this innovation as soon as possible," the company said.

The stock soared 32.18 percent to $4.97 in after-hours trading.

Sierra Oncology Lung Cancer Drug Data to Be Presented at an Oncology Conference

Sierra Oncology Inc SRRA said an abstract for pre-clinical data for its Chk1 inhibitor SRA737 + low dose gemcitabine, or LDG, in combination with immunotherapy has been selected for a late-breaking oral presentation at the American Association of Cancer Research, or AACR, annual meeting 2019 to be held in Atlanta from March 29 to April 3.

"We previously reported that SRA737 activated the innate immune signaling STING pathway and demonstrated significant synergistic anti-tumor activity with immunotherapy in an immunotherapy-refractory small cell lung cancer (SCLC) model," the company said.

The stock rallied 11.54 percent to $2.03 in after-hours trading.

Syneos Reveals SEC Investigation, to Delay Release of Q4 Results

Syneos Health Inc SYNH said it received a notification from the SEC Feb. 21, informing it regarding the commencement of an investigation into its revenue accounting policies, internal controls and related matters.

Subsequently, the company said it is delaying the release of its earnings to allow additional time to complete its Form 10-K for the year ended Dec. 31. It has filed a notification of late filing with the SEC. The company added it now expects to file its Form 10-K within the 15-day extension period.

The stock slumped 27.90 percent to $37.50 in after-hours trading.

See Also: Exact Sciences A 'Must-Own' Growth Stock, Goldman Sachs Says In Upgrade

Translate Bio On Track With its Two Product Candidates

Translate Bio Inc TBIO said its lead candidate MRT5005, currently in development for treating cystic fibrosis, has been advanced to dosing patients in the multiple-ascending dose portion of the Phase 1/2 trial, and is also continuing to progress through increasing doses in the single-ascending dose portion of the trial.

The company said it remains on track to report interim data from the trial in the second half of 2019.

Updating on its second product candidate MRT5201, being evaluated to treat ornithine transcarbamylase deficiency, the company said it plans to complete the additional pre-clinical studies sought for by the FDA after it imposed a clinical hold on the investigational new drug application related to the asset. It said it will likely submit a response to the FDA in the fourth quarter of 2019.

The stock rallied 7.50 percent to $10.55 in after-hours trading.

aTyr Presents Positive Results for its Lung Inflammation Drug

aTyr Pharma Inc LIFE made a poster presentation on its investigational candidate ATYR1923 at the Keystone Symposia 2019 Conference that demonstrated its ability to bind to NRP-2 and down-regulate myeloid cells, specifically neutrophils. ATYR1923 is being evaluated in a Phase 1b/2a study in patients suffering from pulmonary sarcoidosis.

"……these findings help support our belief in the mechanism of action of ATYR1923 to suppress immune engagement in this and other serious and potentially debilitating interstitial lung diseases," the company said.

The penny stock jumped 16.13 percent to 54 cents in after-hours trading.

Earnings

Collegium Pharmaceutical Inc COLL reported fourth-quarter revenues of $73.43 million compared to $10.79 million in the year-ago quarter. The company reversed from a loss of 54 cents to a profit of 27 cents. The revenues were in line with estimates, while the bottom-line results exceeded estimates.

The stock jumped 9.34 percent to $15.80 in after-hours trading.

PRA Health

PRA Health Sciences Inc PRAH reported a 11.2 percent increase in fourth-quarter revenues to $729.6 million, which however were below the consensus estimate of $741.59 million. Adjusted EPS came in at $1.31, exceeding the $1.27 consensus estimate.

For the full-year 2019, the company expects total revenues of $3.09 billion to $3.20 billion and adjusted EPS of $4.93-$5.08. The revenue guidance was in line and the EPS guidance suggested in line to above consensus results.

The stock fell 6.85 percent to $104 in after-hours trading.

On The Radar

Clinical Trial Results

Heat Biologics Inc HTBX is scheduled to present interim Phase 2 data for HS-110 in combination with Bristol-Myers Squibb's Opdivo at the 2019 ASCO-SITC Clinical Immuno-Oncology Symposium meeting at 1 pm PST.

IPO

Kaleido Biosciences said it has priced its upsized initial public offering of 5 million shares at $15, below the estimated price range of $20-$22. The company, which develops microbiome therapies for rare genetic disorders, will list its shares on the Nasdaq under the ticker symbol KLDO.