Top 5 Losers In Healthcare Sector (AGRX, MRUS, BPMC…)

(RTTNews) - The following are some of the healthcare stocks that posted the biggest percentage decline on Monday.

1. Agile Therapeutics Inc. (AGRX)

Agile Therapeutics is a women's healthcare company.

Lost 59.32% to close Monday's (Oct.28) trading at $0.45.

News: In briefing documents released ahead of the FDA panel meeting to review the Company's lead product candidate Twirla, a contraceptive patch, the regulatory agency has expressed a number of concerns regarding Twirla's approvability, including, but not limited to, concerns related to Twirla's efficacy when balanced against its safety.

The FDA also did not appear to agree with the Company's proposal to include a limitation of use based on patient weight and BMI in the product label.

The FDA Advisory Committee Meeting for Twirla NDA is slated for October 30, 2019, with a final decision anticipated on November 16, 2019.

2. TrovaGene Inc. (TROV)

Trovagene is a clinical-stage oncology therapeutics company.

Lost 17.84% to close Monday's trading at $1.75.

News: No news

Clinical Trials & Near-term Catalysts:

The Company's lead product candidate is Onvansertib, which is being tested:

-- in combination with either low-dose cytarabine (LDAC) or decitabine for the treatment of Acute Myeloid Leukemia (AML) under a phase Ib/II trial. -- in combination with Zytiga for the treatment of Metastatic Castration-Resistant Prostate Cancer (mCRPC) in a phase II trial. *This study is expected to be completed in October 2020. (Source: ClinicalTrials.gov) -- and in a phase Ib/II study in combination with FOLFIRI and Avastin for second-line treatment of patients with metastatic colorectal cancer (mCRC) with a KRAS mutation. On October 22, 2019, the Company announced data that demonstrated a positive response to treatment in patients enrolled in this study. *This study is expected to be completed in May 2021. (Source: ClinicalTrials.gov)

3. Tetraphase Pharmaceuticals Inc. (TTPH)

Tetraphase Pharma is a biopharmaceutical company developing novel tetracyclines for serious and life-threatening conditions. The Company's lead product XERAVA is approved for the treatment of complicated intra-abdominal infections by the FDA and the European Medicines Agency.

Lost 17.48% to close Monday's trading at $4.25.

News: No news

Recent event:

On September 27, 2019, the Company implemented a 1-for-20 reverse stock split of its common stock.

4. Merus N.V. (MRUS)

Merus is a clinical-stage immuno-oncology company.

Lost 16.16% to close Monday's trading at $15.51.

News: The Company reported promising initial clinical data for three patients with cancers harboring NRG1 fusions treated with MCLA-128 in a Phase 1/2 clinical trial in solid tumors, dubbed eNRGy, and provided an overall update on the MCLA-128 clinical programs. The eNRGy trial involves Pancreatic Ductal Adenocarcinoma and Non-small cell lung cancer patients.

The Company will not be advancing MCLA-128 into a Phase 3 clinical trial in metastatic breast cancer or gastric cancer in the absence of a collaborator and intends instead to refocus efforts on the MCLA-128 NRG1 eNRGy trial as well as its other clinical and late-stage preclinical pipeline program.

In the eNRGy Clinical Trial, four of seven treated showed clinical activity, two are too early in treatment for first assessment, noted the Company.

5. Blueprint Medicines Corp. (BPMC)

Blueprint Medicines is a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy.

Lost 13.70% to close Monday's trading at $67.05.

News: The Company has announced an update regarding its New Drug Application (NDA) for Avapritinib for the treatment of adults with PDGFRA Exon 18 mutant gastrointestinal stromal tumors (GIST), regardless of prior therapy, and fourth-line GIST.

On August 7, 2019, the FDA notified the Company that a decision on the NDA seeking approval of Avapritinib for the treatment of PDGFRA Exon 18 Mutant GIST and fourth-line GIST will be announced on February 14, 2020.

Now, the FDA has informed the Company that it intends to administratively split the proposed indications for Avapritinib into two separate NDAs, one for PDGFRA Exon 18 mutant GIST, regardless of prior therapy, and one for fourth-line GIST.

The regulatory agency has also sought top-line data from the VOYAGER trial citing that the data would be informative in its review of the proposed fourth-line GIST indication. The top-line from the phase III VOYAGER trial is anticipated in Q2, 2020.