ANAB Makes A Clean Sweep, PTIE Making Gains, Giant Leap By MNKD

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of October 10, 2017.

GAINERS

1. AnaptysBio Inc. (ANAB)

Gained 101.17% to close Tuesday's (Oct.10) trading at $70.41.

News: The Company announced positive proof-of-concept data from its ongoing Phase 2a clinical trial of ANB020 in adult patients with moderate-to-severe atopic dermatitis.

The interim analysis based on 12 patients revealed that after a single dose of ANB020, 75 percent of patients achieved an Eczema Area Severity Index (EASI) score improvement of 50 percent relative to enrollment baseline (EASI-50) at day 15; 83 percent of patients achieved EASI-50 at day 29 and 75 percent of patients achieved EASI-50 at day 57.

Near-term catalysts:

-- Top line data from phase 2a study of ANB020 in adults with severe peanut allergy are expected in the fourth quarter of 2017. -- Top line data from phase 2a study of ANB020 in adults with severe eosinophilic asthma are expected in the first half of 2018. -- Initiate a Phase 2b study in 200-300 adult patients with moderate-to-severe atopic dermatitis to evaluate multi-dose subcutaneous administration of ANB020 during the first half of 2018, with data expected in 2019.

2. KalVista Pharmaceuticals Inc. (KALV)

Gained 38.08% to close Tuesday's trading at $10.19.

News: The Company has entered into a collaboration agreement with Merck for its diabetic macular edema (DME) drug candidate KVD001 and future oral DME compounds. Merck has acquired a 9.9% stake in KalVista at a price of $8.50 per share.

KVD001 is KalVista's investigational intravitreal (IVT) injection candidate currently in development for potential treatment of diabetic macular edema. A phase II trial of KVD001 is expected to be initiated this year.

3. MannKind Corporation (MNKD)

Gained 25.89% to close Tuesday's trading at $6.71.

News: H.C. Wainwright has initiated coverage on MannKind with a Buy.

Recent event:

On October 2, 2017, the FDA approved an update to the Afrezza label, regarding its rapid onset of activity and duration of effect. The Company's stock has gained over 186% since then.

4. Prima BioMed Ltd (PBMD)

Gained 15.28% to close Tuesday's trading at $2.57.

News: No news

Pipeline:

-- The Company's lead product candidate is IMP321, which is under Phase IIb study in metastatic breast cancer, dubbed AIPAC, and phase I study in metastatic melanoma, known as TACTI-mel.

Near-term catalysts:

-- The final immune monitoring and activity data (safety run-in phase) from the AIPAC study expected by the end of 2017. -- Further dose escalation, safety and activity data from the TACTI-mel trial are anticipated to be presented at the World Immunotherapy Congress on October 31, 2017. -- Preclinical data of IMP761, which is being developed for autoimmune diseases, are expected to be presented this year.

5. Pain Therapeutics Inc. (PTIE)

Gained 14.16% to close Tuesday's trading at $4.82.

News: No news

Near-term catalysts:

-- Top line results from abuse potential study via the nasal route of abuse with REMOXY ER expected by year-end 2017. -- Resubmission of the New Drug Application for REMOXY ER in Q1 2018. REMOXY ER was issued a Complete Response Letter by the FDA last September.

REMOXY ER is a proprietary, abuse-deterrent, extended-release oral formulation of oxycodone. The proposed indication for this drug candidate is for "the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate."

6. Marinus Pharmaceuticals Inc. (MRNS)

Gained 12.43% to close Tuesday's trading at $6.33.

News: No news

Near-term catalysts:

-- Initiate a phase II study of Ganaxolone capsules in women with moderate Postpartum Depression, dubbed Amaryllis, later this year. -- Initiate a phase II study of Ganaxolone IV in patients with status epilepticus later this year.

7. ObsEva SA (OBSV)

Gained 11.36% to close Tuesday's trading at $9.80.

News: The Company has entered into a $60.0 million private placement with existing and new investors.

The common shares are priced at $8.00 per share and the prepaid warrants are immediately exercisable at a price of $8.00 per share and will expire in 30 days. The private placement is expected to close on or about October 13th, 2017.

Pipeline & Catalysts:

The Company's most advanced investigational drug is OBE2109, under phase III clinical trials for the treatment of heavy menstrual bleeding (HMB) associated with uterine fibroids (UF) in pre-menopausal women, dubbed PRIMROSE 1 and PRIMROSE 2. A Phase 2b clinical trial of OBE2109 for the treatment of pain associated with endometriosis (EM), dubbed EDELWEISS, is also underway.

Also in the pipeline are Nolasiban to improve pregnancy and live birth rates in women undergoing assisted reproduction by in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) for low fertility, and OBE022 for the treatment of preterm labor.

Nolasiban advanced to phase III testing as recently as March of this year. The phase III trial, known as IMPLANT2, is being conducted at approximately 50 fertility clinics across Europe, and is expected to enroll about 760 women who have undergone assisted reproduction technology (ART).

The Company expects to complete enrollment in its phase III IMPLANT 2 trial of nolasiban for ART by the end of 2017, with top line data expected in the first half of 2018.

The phase 2b EDELWEISS trial of OBE2109 for the treatment of endometriosis is expected to complete enrollment in late 2017 or early 2018, with data expected from the first 12-week evaluation period around mid-2018.

OBE022 for pre-term labor is expected to move into a Phase 2a clinical trial, dubbed PROLONG, in the fourth quarter of 2017, with top line data release expected around year end 2018.

8. Mesoblast Limited (MESO)

Gained 10.15% to close Tuesday's trading at $6.70.

News: No news

Near-term catalysts:

-- The Phase 2b trial using MPC-150-IM in 159 end-stage CHF (congestive heart failure) patients with a LVAD completed enrollment last month, with top-line results expected in Q1 CY18. -- The Phase 3 trial using MPC-150-IM in patients with Class II/III CHF is continuing to enrol through FY18, with full enrollment expected to occur in 2H CY18. -- The Phase 3 trial using MSC-100-IV in children with steroid refractory acute Graft-versus-host disease (GVHD) is expected to complete enrollment with top-line data readout expected in 2H CY17. -- The Phase 3 trial using MPC-06-ID in patients with chronic low back pain is expected to complete enrollment in Q4 CY17. -- 12-month results for the Phase 2 trial using MPC-300-IV in patients with biologic-refractory rheumatoid arthritis are expected in Q3 CY17.

9. Ovid Therapeutics Inc. (OVID)

Gained 8.42% to close Tuesday's trading at $9.14.

News: The FDA has granted orphan drug designation for OV101 for the treatment of Fragile X syndrome.

The Company made its debut on the NASDAQ Global Select Market on May 5, 2017, offering its shares at a price of $15.00 each.

Pipeline:

The Company's pipeline includes OV101, a potential treatment for Angelman syndrome and Fragile X syndrome, and TAK-935/OV935 for treatment of adults with rare epilepsies. A phase II clinical trial of OV101 in adults with Angelman syndrome, dubbed STARS, a phase I trial of OV101 in adolescents diagnosed with Angelman syndrome or Fragile X syndrome, and a phase 1b/2a clinical trial of TAK-935/OV935 in adults with rare epilepsies are underway.

Near-term catalysts:

-- The top line data from the phase I trial evaluating OV101 in adolescents diagnosed with Angelman syndrome or Fragile X syndrome are expected to be available in the second half of 2017. -- Data from the phase 1b/2a clinical trial of TAK-935/OV935 are expected next year.

LOSERS

1. Catabasis Pharmaceuticals Inc.(CATB)

Lost 11.76% to close Tuesday's trading at $2.25.

News: No news

Recent event:

On October 4, the Company reported positive results from open-label extension of Phase 2 MoveDMD trial evaluating Edasalonexent in Duchenne Muscular Dystrophy.

Near-term catalysts:

Catabasis plans to initiate a single global Phase 3 trial with Edasalonexent in patients with DMD regardless of mutation type in the first half of 2018 with top-line results expected in 2020.

2. INSYS Therapeutics Inc. (INSY)

Lost 9.35% to close Tuesday's trading at $7.85.

News: No news

Recent event:

-- On September 29, 2017, the Company filed a New Drug Application for a novel formulation of buprenorphine as a sublingual spray for the management of moderate-to-severe acute pain with the FDA.

3. Tandem Diabetes Care Inc. (TNDM)

Lost 8.70% to close Tuesday's trading at $5.30.

News: No news

Recent event:

-- On October 10, 2017, the Company effected a 1 for 10 reverse stock split.