AIMT Gains As DBVT Bleeds, PETS Gets Attention, FLDM On Watch

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of October 23, 2017.

GAINERS

1. Aimmune Therapeutics Inc. (AIMT)

Gained 28.37% to close Monday's (Oct.23) trading at $32.94.

News: No news

Near-term catalyst:

-- The Company is expected to discuss global screening data from its phase III PALISADE trial on October 27, 2017.

The PALISADE trial is designed to investigate the efficacy and safety of AR101 in peanut-allergic children, adolescents, and adults. The top line data from this trial are expected to be available in the first quarter of 2018.

Recent event:

-- On October 16, 2017, Aimmune entered into a clinical collaboration with Regeneron (REGN) and its strategic alliance collaborator Sanofi (SNY) to study AR101 treatment with adjunctive *dupilumab in peanut-allergic patients in a Phase 2 clinical trial. Regeneron's Dupilumab, approved on March 28, 2017, is indicated for the treatment of adult patients with inadequately controlled moderate-to-severe atopic dermatitis. It is sold under the brand name Dupixent.

2. PetMed Express Inc. (PETS)

Gained 18.15% to close Monday's trading at $43.41.

News: The Company has reported better-than-expected Q3, 2017 financial results.

Net income for the quarter ended September 30, 2017 was $8.8 million or $0.43 per share, on net sales of $66.7 million. Analysts polled by Thomson Reuters expected the Company to earn $0.30 per share on revenue of $63.36 million.

The Company posted a net income of $4.9 million or $0.24 per share and revenue of $60.8 million for the quarter ended September 30, 2016.

The Board of Directors declared a quarterly dividend of $0.20 per share on the Company's common stock. The dividend will be payable on November 17, 2017, to shareholders of record at the close of business on November 6, 2017.

3. KalVista Pharmaceuticals Inc. (KALV)

Gained 15.63% to close Monday's trading at $13.02.

News: No news

Recent event:

-- On October 6, 2017, KalVista and Merck initiated a collaboration for KVD001, KalVista's intravitreal DME program, as well as future orally delivered plasma kallikrein inhibitors for DME developed by KalVista.

Near-term catalyst:

-- Initiate Phase 2 proof-of-concept trial of intravitreal KVD001 for Diabetic Macular Edema later this year.

4. Tandem Diabetes Care Inc. (TNDM)

Gained 11.07% to close Monday's trading at $2.81.

News: No news

Recent event:

-- A 1-for-10 reverse stock split was effected on October 10, 2017.

Near-term catalyst:

The Company plans to release its third quarter 2017 results after the financial markets close on Thursday, October 26, 2017.

5. Fluidigm Corporation (FLDM)

Gained 8.75% to close Monday's trading at $5.47.

News: No news

Near-term catalyst:

The Company is slated to report third quarter 2017 financial results on Thursday, November 2, 2017, after the financial markets close.

Analysts polled by Thomson Reuters expect the Company to incur a loss of $0.47 per share on revenue of $25.54 million in Q3, 2017.

LOSERS

1. DBV Technologies S.A. (DBVT)

Lost 41.09% to close Monday's trading at $28.32.

News: The Company's phase III trial of Viaskin Peanut in children four to 11 years of age failed to meet its primary endpoint.

In the trial, dubbed PEPITES, Viaskin Peanut 250 µg after 12 months of treatment did not reach the 15% lower bound confidence interval (CI) in the difference in response rates between the active and placebo arms.

Near-term catalyst:

Another phase III trial of Viaskin Peanut, dubbed REALISE, is underway. Results from this trial are expected in November 2017.

2. MannKind Corporation (MNKD)

Lost 9.98% to close Monday's trading at $3.70.

News: The Company announced the restructuring of certain of its outstanding debt obligations and submission of a registration dossier to Brazilian Health regulatory Agency, seeking approval of Afrezza inhalation powder in Brazil.

Recent events:

-- On October 11, 2017, the Company announced a registered direct offering of an aggregate of 10.16 million shares of common stock at an offering price of $6.00 per share, for gross proceeds of approximately $61 million. The offering was expected to close on or about October 13, 2017. -- On October 2, 2017, the FDA approved an update to the Afrezza label, regarding its rapid onset of activity and duration of effect.

3. Flex Pharma Inc. (FLKS)

Lost 11.06% to close Monday's trading at $3.01.

News: No news

Near-term catalyst:

-- A phase II trial evaluating FLX-787 in patients with Charcot-Marie-Tooth, who suffer from painful, debilitating cramps is underway. Topline results from this study are expected in the middle of 2018.

4. Novelion Therapeutics Inc. (NVLN)

Lost 9.16% to close Monday's trading at $5.95.

News: No news

Recent event:

-- On August 8, 2017, the Company lowered its revenue outlook for 2017 to a range of $135 million to $145 million from its prior outlook range of between $155 million and $165 million.

5. BioCryst Pharmaceuticals Inc. (BCRX)

Lost 8.96% to close Monday's trading at $4.37.

News: No news

Recent event:

-- On September 21, 2017, the FDA approved a supplemental New Drug Application for RAPIVAB, extending its availability for the treatment of acute uncomplicated influenza to pediatric patients 2 years and older who have been symptomatic for no more than two days.

RAPIVAB was first approved in December 2014 to treat influenza infection in adults.

6. Endocyte Inc. (ECYT)

Lost 8.48% to close Monday's trading at $4.75.

News: No news

Recent event:

-- On October 2, 2017, the Company announced a deal with ABX GmbH, in-licensing its proprietary ligand PSMA-617. The transaction provides Endocyte with 177Lu-PSMA-617, a phase III-ready prostate cancer drug. The news sent the stock soaring over 157% that day to $3.63, and it gained another 80% to touch a high of $6.55 the following day. Endocyte plans to seek regulatory approval to initiate a phase III registration trial of 177Lu-PSMA-617 in early 2018. If all goes well as planned, the Company expects to complete the trial as early as 2020.

7. Aeglea Biotherapeutics Inc. (AGLE)

Lost 8.32% to close Monday's trading at $4.63.

News: No news

Pipeline:

-- A phase 1/2 trial of AEB1102 for the treatment of Arginase 1 Deficiency, and two phase I trials of AEB1102 in cancer patients with advanced solid tumors and with hematological malignancies are underway.

Near-term catalysts:

-- Top-line results from phase I study of AEB1102 in cancer patients with advanced solid tumors are expected in 4Q2017/1Q2018. -- Top-line results from phase I study of AEB1102 in patients with hematological malignancies are expected in 4Q2017/1Q2018. -- Top-line results from phase 1/2 trial of AEB1102 for the treatment of Arginase 1 Deficiency are anticipated in the second half of 2018.

8. Advaxis Inc. (ADXS)

Lost 7.65% to close Monday's trading at $3.50.

News: No news

Near-term catalysts:

-- Completion of the MAA submission for conditional approval of Axalimogene filolisbac in recurrent metastatic, cervical cancer in Europe is expected in the fourth quarter of this year. -- Filing of IND for combination trial with ADXS-DUAL and Bristol Myers' Opdivo for the treatment of women with persistent, recurrent or metastatic cervical cancer is expected in the remainder of this year, with initiation of the trial planned for the first half of 2018. -- Initiation of phase I trial of ADXS-NEO in multiple tumor types is expected in 1H 2018.